![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 4 to 28 of 28. Go back in thread:
Posted by Bob on August 30, 2003, at 14:28:17
In reply to Surgery tomorrow: removal of VNS implant, posted by jerrympls on August 28, 2003, at 21:48:57
> Hey everyone-
>
> Tomorrow morning I am having my Vegal Nerve Stimulator implant removed. It's a 3 hour surgery. The device just didn't help my depression after 2 years on it.
>
> Anyway, I'm kinda nervous...it's gonna be a painful recovery. Wish me well....
>
> thanks
> JerryHey Jerry:
Just saw this, and was hoping everything went ok with the explant. I hope it wasn't as painful as you were anticipating, and that you have a speedy recovery. I'm very sorry it didn't work for you.
When you are feeling better, I would like to communicate with you about some of the aspects of your experience (if Cyberonics lets you, of course). I have been thinking about getting that thing for almost three years now. My e-mail address is: rizzoroba at comcast dot net.
Thanks, and good luck.
Bob
Posted by Ponder on August 31, 2003, at 14:45:06
In reply to Re: Surgery tomorrow: removal of VNS implant » jerrympls, posted by Bob on August 30, 2003, at 14:28:17
Jerry,
I can't even begin to express the waves of emotion I felt at reading your post. I, too, have had a VNS implant since December of 2000. Evaluating the efficacy has been nearly impossible for me, given all the med changes that have gone on in the meantime. So, I've wondered if I should keep going around zapping my vagus nerve for the rest of my life thinking that it MAY be helping a little bit, or call it quits and get the thing taken out.Did you have it turned off for a while to see if there was a difference?
I had some slight, but noticeable improvement in my cognitive functioning when they first activated the device. So now I'm scared to keep it, scared to give it up.
I hope you're doing well. I'll be very interested in your experience with explantation and recovery since that may be in my future as well.
Posted by Bob on August 31, 2003, at 16:51:56
In reply to Jerry, posted by Ponder on August 31, 2003, at 14:45:06
> Jerry,
> I can't even begin to express the waves of emotion I felt at reading your post. I, too, have had a VNS implant since December of 2000. Evaluating the efficacy has been nearly impossible for me, given all the med changes that have gone on in the meantime. So, I've wondered if I should keep going around zapping my vagus nerve for the rest of my life thinking that it MAY be helping a little bit, or call it quits and get the thing taken out.
>
> Did you have it turned off for a while to see if there was a difference?
>
> I had some slight, but noticeable improvement in my cognitive functioning when they first activated the device. So now I'm scared to keep it, scared to give it up.
>
> I hope you're doing well. I'll be very interested in your experience with explantation and recovery since that may be in my future as well.Your experience is one of the two scenarios I fear if I get implanted with this device. The other scenario is it actually does "too much" and makes me worse. If this thing ever does get approved, I would assume it is because it is actually helping someone out there, right?
Ever notice how unbelievably difficult the treatment decisions are for the extremely depressed? Often, one knows that a change is needed, as the current regimen isn't cutting it. However, the change itself will bring misery, and so is therefore avoided.
Posted by jerrympls on August 31, 2003, at 19:25:19
In reply to Re: Jerry » Ponder, posted by Bob on August 31, 2003, at 16:51:56
Hello all-
I'm doing well recovering. Just have some pain (of course) and can only whisper right now (it usually takes a couple days for my vocal chords to "recover" from the surgery as well).
PONDER- I too had some mild improvemnt when they first turned on the device. It was almost unreal - overnight my anxiety disappeared and for a couple weeks I felt very close to "normal." It didnt' stick for me however. They tried various settings while trying various med combinations trying not to change one while changing the other.
I've heard that a couple in my area in the study have elected to get theirs removed as well. I have also heard that this has helped many too.
One of my main reasons for finally having it removed was it was making my asthma worse. For some with asthama they are able to tolerate it wih some adjustments of the settings - but it always effected my asthma.
I had it turned off 3 months before having it out. No change in mood. I don't thinki tmade me worse - it just didn't work. They finally put me on Nardil and that has been working really well.
I'll post more later....gotta rest....
Thanks for all your thoughts....
Jerry
Posted by LifeTime on September 8, 2003, at 0:55:28
In reply to Re: Jerry, posted by jerrympls on August 31, 2003, at 19:25:19
Dear Jerry,
I’m not a regular reader of Dr. Bob’s website but I recently communicated with him about my wife’s favorable experience with the VNS and he directed me to this site.
First, I am sorry that you did not find the device efficacious for your purposes and I do wish you a very speedy recovery from the explanting procedure. Before I give you and the other folks some information on our experiences I would appreciate if you could answer several questions for me.
1- What was the highest amplitude setting on your VNS that you ever attempted and over how many days did you leave that highest setting?
2- When they explanted your VNS did they also remove the two coils around the vagal nerve or did they just clip the lead wires as close to the coils and left them in place?
Your responses would be much appreciated. Incidentally, all the restrictions on the study participants have been removed. I am an active message board member on the Cyberonics website and I post under the name of “Herb.” I am a long time support person, caregiver, healthcare advocate and depression lay-expert to my wife as well as a former facilitator, board member, president of a local chapter of the DBSA and a state appointment as a Guardian Advocate.
My spouse was implanted in December 1999 as part of the initial D-01 depression study. We have battled MDD (Major Depressive Disorder) some thirty-eight years. The road to achieving our goals has required a “trial and error approach” to wellness. To make a long story short, where Cyberonics did not allow any public communication from the study subjects and their support people, I formed collaboration privately with a number of recipients. This collaboration proved for us to be extremely beneficial.
My wife is depression free and off all psychotropic medications for purposes of depression. Adding to the remarkable results is the fact that any situational and/or environmental stresses and/or upsets no longer have a lasting effect upon her mood. She simple gets over the event and carries on with her life. These events no longer cause her to spiral downward into severe depressive episodes.
Her illness is controlled, stabilized and in remission. We are cautiously optimistic that after all these years we have achieved our goals of wellness and long-term remission of her illness. Another young woman with whom I communicate is also depression free without medications at higher settings. It has taken us time to achieve these results as we theorized that the higher amplitudes were the efficacious levels and we directed the researchers to follow our instructions and theorizes. In my wife’s case it took us some time to achieve those higher settings. We were already on our road to wellness when the failed D-02 study results were published and the CEO explained that the minimum settings for the protocol should have been 1.50 mA. We were above that setting, at that point in time, and therefore the reason for my question to you previously about your highest settings.
Again, we are sorry you were not one of those being helped by the device but we do extend our very best wishes to you for wellness.
Anyone interested in discussing the device might want to check out the Cyberonics message boards:
http://www.vnstherapy.com/messagsfs.html
Disclosure:Any one reading my posting please understand that I am a very long-term caregiver, support person and depression lay-expert to my spouse as well as a former DBSA facilitator, president, board member of a local chapter and a state appointment as a Guardian Advocate. I am not endorsing the use of any medication(s), treatment(s) and/or therapy(s). I am just trying to share some of our experiences, research, knowledge and readings over these many years in the hope it may benefit the reader. We have also greatly benefited in knowledge and friendship from the local support groups in our area including the DBSA (formerly the DMDA) and NAMI. Most importantly consult with a caring, compassionate and knowledgeable licensed healthcare professional.
.
Posted by Bob on September 8, 2003, at 1:01:29
In reply to Re: Jerry, posted by LifeTime on September 8, 2003, at 0:55:28
> Dear Jerry,
>
> I’m not a regular reader of Dr. Bob’s website but I recently communicated with him about my wife’s favorable experience with the VNS and he directed me to this site.
>
> First, I am sorry that you did not find the device efficacious for your purposes and I do wish you a very speedy recovery from the explanting procedure. Before I give you and the other folks some information on our experiences I would appreciate if you could answer several questions for me.
>
> 1- What was the highest amplitude setting on your VNS that you ever attempted and over how many days did you leave that highest setting?
>
> 2- When they explanted your VNS did they also remove the two coils around the vagal nerve or did they just clip the lead wires as close to the coils and left them in place?
>
> Your responses would be much appreciated. Incidentally, all the restrictions on the study participants have been removed. I am an active message board member on the Cyberonics website and I post under the name of “Herb.” I am a long time support person, caregiver, healthcare advocate and depression lay-expert to my wife as well as a former facilitator, board member, president of a local chapter of the DBSA and a state appointment as a Guardian Advocate.
>
> My spouse was implanted in December 1999 as part of the initial D-01 depression study. We have battled MDD (Major Depressive Disorder) some thirty-eight years. The road to achieving our goals has required a “trial and error approach” to wellness. To make a long story short, where Cyberonics did not allow any public communication from the study subjects and their support people, I formed collaboration privately with a number of recipients. This collaboration proved for us to be extremely beneficial.
>
> My wife is depression free and off all psychotropic medications for purposes of depression. Adding to the remarkable results is the fact that any situational and/or environmental stresses and/or upsets no longer have a lasting effect upon her mood. She simple gets over the event and carries on with her life. These events no longer cause her to spiral downward into severe depressive episodes.
>
> Her illness is controlled, stabilized and in remission. We are cautiously optimistic that after all these years we have achieved our goals of wellness and long-term remission of her illness. Another young woman with whom I communicate is also depression free without medications at higher settings. It has taken us time to achieve these results as we theorized that the higher amplitudes were the efficacious levels and we directed the researchers to follow our instructions and theorizes. In my wife’s case it took us some time to achieve those higher settings. We were already on our road to wellness when the failed D-02 study results were published and the CEO explained that the minimum settings for the protocol should have been 1.50 mA. We were above that setting, at that point in time, and therefore the reason for my question to you previously about your highest settings.
>
> Again, we are sorry you were not one of those being helped by the device but we do extend our very best wishes to you for wellness.
>
> Anyone interested in discussing the device might want to check out the Cyberonics message boards:
>
> http://www.vnstherapy.com/messagsfs.html
>
>
> Disclosure:
>
> Any one reading my posting please understand that I am a very long-term caregiver, support person and depression lay-expert to my spouse as well as a former DBSA facilitator, president, board member of a local chapter and a state appointment as a Guardian Advocate. I am not endorsing the use of any medication(s), treatment(s) and/or therapy(s). I am just trying to share some of our experiences, research, knowledge and readings over these many years in the hope it may benefit the reader. We have also greatly benefited in knowledge and friendship from the local support groups in our area including the DBSA (formerly the DMDA) and NAMI. Most importantly consult with a caring, compassionate and knowledgeable licensed healthcare professional.
>
>
> .
That is truly, truly, awesome news. It is so good to hear that someone, somewhere has (at least it seems) climbed out of the black whole of death. Man, that is really somewhat encouraging!
Posted by LifeTime on September 9, 2003, at 0:24:02
In reply to Surgery tomorrow: removal of VNS implant, posted by jerrympls on August 28, 2003, at 21:48:57
Dear Dr. Bob,
I omitted in my previous posting to indicate that my wife has achieved 10 continuous months depression free and she has now been off psychotropic medications for purposes of depression for 24 months. Your descriptive expression “black whole of death” is a good one. I’ve often used “depression death spiral” as my spouse unsuccessfully attempted suicide on 5 different occasions. Naturally, the true test in my mind would be if I can come back to this board and inform the readers that she has had 10 continuous years of wellness. We live our lives one day at a time and right now the 10 continuous months, for us, feels like an eternity.
What is important is that it is all behind us and she is so very happy to be alive today. We now concentrate on all the positives in our lives. I would like to encourage all those that suffer from these horrific illnesses and their support people to remember what I consider the most important word in all of life, “PERSISTENCE.” It has taken us 38 years to achieve my spouse’s wellness, it is possible. Remain ‘PERSISTENT” and do not give up hope.
Jerry (jerrympls),I would appreciate if you could respond to my questions or if anyone happens to know Jerry and if you could please ask him to respond.
Thank you all.
.
Posted by jerrympls on September 9, 2003, at 7:27:50
In reply to Re: Surgery tomorrow: removal of VNS implant, posted by LifeTime on September 9, 2003, at 0:24:02
> Dear Dr. Bob,
>
> I omitted in my previous posting to indicate that my wife has achieved 10 continuous months depression free and she has now been off psychotropic medications for purposes of depression for 24 months. Your descriptive expression “black whole of death” is a good one. I’ve often used “depression death spiral” as my spouse unsuccessfully attempted suicide on 5 different occasions. Naturally, the true test in my mind would be if I can come back to this board and inform the readers that she has had 10 continuous years of wellness. We live our lives one day at a time and right now the 10 continuous months, for us, feels like an eternity.
>
> What is important is that it is all behind us and she is so very happy to be alive today. We now concentrate on all the positives in our lives. I would like to encourage all those that suffer from these horrific illnesses and their support people to remember what I consider the most important word in all of life, “PERSISTENCE.” It has taken us 38 years to achieve my spouse’s wellness, it is possible. Remain ‘PERSISTENT” and do not give up hope.
>
>
> Jerry (jerrympls),
>
> I would appreciate if you could respond to my questions or if anyone happens to know Jerry and if you could please ask him to respond.
>
> Thank you all.
>
> .
>Hi! I will respond - I have to run off to work but plan to respond to comments later tonight!
Thanks!
Jerry
Posted by LifeTime on September 9, 2003, at 10:54:12
In reply to Re: Surgery tomorrow: removal of VNS implant » LifeTime, posted by jerrympls on September 9, 2003, at 7:27:50
Dear Jerry,
I am extremely glad to also read that you “have to run off to work.” To me, as a support person and caregiver, that is an extremely important and favorable sign. I do hope all continues to go well for you.
1- If you don’t mind, I would appreciate if you could also tell me which study site you were affiliated with?
2- I presume that you were part of the D-02 double blind study?
3- Do you know if you were initially activated or were you part of the placebo group?
4- When you were activated, how did you actually know you were activated?
5- Did you experience any noticeable side effects?
6- You mentioned, at first that you began to feel some relief and then it sort of stopped having a positive effect. Did you attempt any adjunctive treatments? If so, would care to share with us?
7- Was there any specific reason that prompted you to decided to explant the device?
8- Did anyone make a recommendation to you to deactivate the device for a period of time and then try reactivating to see what happens?Although we live in South Florida my wife’s doctor, Dr. Paul Goodnick was associated with the Univ. Of Miami School of Medicine and he was instrumental in helping to get her into the initial study at the Medical Univ. of South Carolina in Charleston. As part of the deal we had to agree to move to Charleston for three months during the acute phase of the study. We still continue to travel up to Charleston, on a quarterly basis, as part of our agreement. Until the FDA approves the device they remain responsible for her care.
Your situation and case history is of much interest to me. I don’t me to pry into anything that you do not wish to divulge. As I indicated, the gag order has been removed and I have all along made a sincere effort to share our experiences, research and knowledge with a number of VNS study recipients as well as others that suffer MDD. Although my spouse is depression free I still continue my research, readings and collaborations as a backup and safety net, just in case. Her case history has been filled with numerous refractory episodes to various treatments so in a sense I personally can never quite get too comfortable and complacent.
I look forward to your sharing you’re experiences and knowledge with us. Also, if you don’t mind, I would like to write to you personally. Is this acceptable to you and has you’re E-mail remained the same as listed on this message board?
Once again, thanks for taking the time to share with us and our best wishes for your wellness.
.
Posted by dazedandconfused on September 9, 2003, at 15:43:27
In reply to Re: Surgery tomorrow: removal of VNS implant, posted by LifeTime on September 9, 2003, at 10:54:12
Hello there...this is off topic as I have no experience with VNS,,,however I had to write when I saw you were from South Florida and worked with Dr. Goodnick. I am looking for a PDOC and I heard he was one of the best,,,unfortunately he has relocated out of state. Has your spouse found another PDOC in Miami to work with? Does she go through U of M for testing, etc. Also, does your spouse work with a therapist?
Thanks in advance. I am really desperate to find someone find a GOOD PDOC! (fyi, my diagnosis is major depression, some OCD tendencies).
Thanks again.
Posted by Ponder on September 9, 2003, at 16:44:36
In reply to Re: Surgery tomorrow: removal of VNS implant, posted by LifeTime on September 9, 2003, at 0:24:02
Dear Lifetime,
As indicated in a previous post, I am also a VNS study participant. I would like to congratulate you and your wife on your success and on your determination to find something that works.My results have not been so unequivocal. My diagnosis is bipolar and I have not been able to go without medications. This has vastly complicated that challenge of evaluating the efficacy of VNS for me. I still experience cycling, although I have not been in that hypersomnulent, heavy depression mode since having recovered from the last big one that sent me begging to get into the study. This could be an improvement from VNS or it could be my historical pattern of having completely incapacitating depressions every few years with lesser impairment in between.
I will be curious also about Jerry's experience with respect to removal of the leads. That part concerns me.
I don't know what my settings are, but I was one of the people they ramped up after the initial study results.
I still have problems with anxiety, which actually have worsened somewhat. I was surprised when I heard that Cyberonics was doing a pilot on treatment of anxiety with VNS.
Thanks for your post. It is heartening to hear.
Posted by LifeTime on September 9, 2003, at 17:58:30
In reply to Re: Surgery tomorrow: removal of VNS implant » LifeTime, posted by dazedandconfused on September 9, 2003, at 15:43:27
Dazedandconfused,
We live in Broward County but traveled down to the Univ. of Miami School of Medicine because of our six year relationship with Dr. Goodnick. Unfortunately he has relocated to New Jersey. He was my wife’s doctor but my mentor and collaborator. We still maintain collaboration and I discuss all our thoughts with him as it pertains to my wife’s healthcare needs. Before he left he gave all his patients his recommendations for new doctors. We chose one of his students who he expressed much confidence in. You could call directly to the Univ. of Miami School of Medicine and ask for a recommendation if you are geographically close to the facility. We currently are using Dr. Goodnick’s former student, Dr. Mark Antonio Hernandez, as her pdoc. He works out of Weston, FL and Boca Raton. I am not certain if he has offices in Miami. His telephone number is (954) 389-5563. My wife likes him but quite frankly all that they do, right now, is tell each other jokes and he interrogates her VNS device. We have not been hard pressed to need his expertise, fortunately. Quite frankly, with all due respect to many of the practitioners I am probably more up to date on current research than they are. I am a very forceful and vocal advocate for my spouse’s healthcare needs that I arranged for her doctor to get the equipment to interrogate her device instead of us having to go to Miami. While Dr. Goodnick was affiliated with the University I had his staff checkout her device periodically.
My wife continues using a Psychotherapist. His name is Rick Harris, PsyD. His telephone number is (954) 217-2444. He too practices out of Weston, FL. She likes him, so I’m happy.
I do recall several folks mentioning that they were happy with a Psychologist at the U of M. I recall her name was Blanche Fruend. You might want to check her out and then see who she recommends.
As further assistance you might also want to inquire about the local support groups such as DBSA. They often can recommend doctors from personal experiences and it might also be beneficial to you to form a support network for yourself. They operate a number of support groups in Broward and Dade. Ask for Chuck at (954) 923-0073 or Ven - (954) 457-7697 for information. You might also check out the following link for informational purposes:
Good luck and remain “PERSISTENT.”
.
Posted by LifeTime on September 9, 2003, at 22:07:23
In reply to Another VNS study participant » LifeTime, posted by Ponder on September 9, 2003, at 16:44:36
Ponder,
I must have missed your posting indicating that you too are a VNS recipient. I would also like to ask of you many of the same questions that I presented to Jerry.
As a very forceful and vocal advocate for my spouse’s healthcare needs, these many years, I make an effort to share our experience, research and knowledge. One of the most important tools I’ve passed along to those who I have collaborated with, as it pertains to the VNS and all treatments, was to maintain a detailed diary and to make certain that they knew precisely all their VNS settings, details of any adjunctive treatment(s) and to strongly advocate for their own wellness.
I am somewhat dismayed and disheartened by your statement,
“I don't know what my settings are, but I was one of the people they ramped up after the initial study results.”
I knew all my wife’s settings. We discussed our theory with the researchers and when no valid explanations and/or reasoning could be given to the contrary we insisted upon our theory being executed. In collaboration with several recipients we concluded that the higher amplitudes may well be more efficacious for the depression subjects based upon our readings from the epilepsy community.
I would appreciate if you could elaborate in more detail what you mean when you indicated “I was one of the people they ramped up after the initial study results?”
I realize that every treatment and therapy will not be 100% efficacious for 100% of the consumers. Since there are no definitive settings for the VNS and like all medication(s), treatment(s) and therapy(s) for this illness we have to use a “trial and error approach” to wellness only I personally believe that encompasses the higher amplitudes.
For informational purposes only I am listing my wife’s current settings. This is not an endorsement to do as we do but is information that one might want to be discussing with a caring, compassionate and knowledgeable licensed healthcare practitioner.
VNS Settings
Output Current (milliamperes) 2.25
Signal Frequency (Hertz) 20
Pulse Width (microseconds) 130
Signal On Time (seconds) 60
Signal Off Time (minutes) 3
Magnet Current (milliamperes) 2.50
Magnet On Time (seconds) 7
Magnet Pulse Width (microseconds) 500Good luck to you too and I look forward to your responses.
.
Posted by Ponder on September 10, 2003, at 11:52:31
In reply to Re: Another VNS study participant, posted by LifeTime on September 9, 2003, at 22:07:23
LifeTime,
Thank you for listing your wife's VNS settings. I tend to be very aware of my treatments with respect to pharmaceuticals, but had the impression that the "blinding" in the study precluded the investigators from sharing that information with me. I will inquire next visit.Regarding being "ramped up": At one point in the study they realized that most people may have been on subtherapeutic levels of stimulation. (I believed you referenced this in one of your previous posts.) At that time, they called in many of the patients, and stepped up the stimulation levels. I was one of those.
It's my understanding that Cyberonics has not yet been able to determine if intensity or frequency most correlates with efficacy. Am I mistaken about this?
My healthcare providers outside of the University clinic take NO INTEREST WHATSOEVER in my stimulator. It's as if they do not want to take the time to read any of the information I provide about it, assuming they'll never have another patient who has one. This has been disheartening to me. It's tough getting coordinated care. (Yes, I know, I'm whining a little here.) :-)
Posted by Bob on September 10, 2003, at 13:03:27
In reply to Re: Another VNS study participant » LifeTime, posted by Ponder on September 10, 2003, at 11:52:31
> LifeTime,
> Thank you for listing your wife's VNS settings. I tend to be very aware of my treatments with respect to pharmaceuticals, but had the impression that the "blinding" in the study precluded the investigators from sharing that information with me. I will inquire next visit.
>
> Regarding being "ramped up": At one point in the study they realized that most people may have been on subtherapeutic levels of stimulation. (I believed you referenced this in one of your previous posts.) At that time, they called in many of the patients, and stepped up the stimulation levels. I was one of those.
>
> It's my understanding that Cyberonics has not yet been able to determine if intensity or frequency most correlates with efficacy. Am I mistaken about this?
>
> My healthcare providers outside of the University clinic take NO INTEREST WHATSOEVER in my stimulator. It's as if they do not want to take the time to read any of the information I provide about it, assuming they'll never have another patient who has one. This has been disheartening to me. It's tough getting coordinated care. (Yes, I know, I'm whining a little here.) :-)
>
>You're not whining. It's very interesting - especially the part about the other healthcare providers not caring.
About the revelation of settings, I would think that after the double blind period is over, it's ok to share.
Posted by LifeTime on September 10, 2003, at 15:12:26
In reply to Re: Another VNS study participant » Ponder, posted by Bob on September 10, 2003, at 13:03:27
Ponder,
What you describe as “whining” is the same unhappiness and discontentment I heard from a number of the other study subjects. Quite frankly and with all do respect to the researchers they really didn’t know their “asses from their elbows.” After a number of the subjects related to me similar complaints and bad experiences I told them of our experiences and what we did. I realize you were in the D-02 study and they were trying to blind the subjects but once the acute phase of the study was over and failed, I encouraged a number of the participants to advocate and empower themselves and several just did that. What is interesting was a comment from several of the people. They said that those that began to actively participate in their healthcare were the ones that seemed to do better. Naturally I cannot substantiate or valid the statement nor can I factually validate whether the higher amplitudes is the key. The fact is the D-02 failed not because the device isn’t efficacious but the protocol was improperly written. They allowed the researchers to set the amplitude at what ever levels were comfortable for the subject and/or the researcher. As it turned out the CEO said the minimum level for the acute phase should have been 1.50 mA and at that time they began to raise the amplitude. Whether the frequency, pulse width, on time or off time plays an important factor remains to be seen. I can tell you from our experiences we had to lower the pulse width and frequency in order to obtain the higher amplitudes without uncomfortable side effects for my wife. At the current settings she feels absolutely nothing. The device is now causing her no side effects and it is functioning properly.
We also have collaborated on another theory based upon the fact that some participants were unable to achieve the higher amplitudes. We call our theory the “Therapy Factor.”
The “Therapy Factor” is a formula:
amplitude x pulse width x frequency x on time / off time = Therapy Factor
What we arrived at is the fact that do to side effects some of the folks could not achieve the higher amplitudes so we deduced if you increase the on time and reduce the off time you can come close to or equal to the same “Therapy Factor” as having a higher amplitude.
The point is in our minds we have the same sort of problems as one would take medications. No two people respond exactly the same but from our little group; those on the higher amplitudes or higher “Therapy Factor” are advising me they are doing better.
I can only encourage you to empower yourself and get involved. The acute phase is long past and the open phase, where they activated all the placebo subjects from D-02, is also finished. Continue to report to your group as scheduled to maintain their contractual obligations to care for you until the device is FDA approved but lean on them, get your information and tell them what you want to do to achieve your wellness.
1- If you don’t mind, I’d appreciate knowing what study site you’re affiliated with?
2- What date was your implantation?
3- Do you know if you were a placebo subject?
4- If you don’t know if you were a placebo subject, did you experience any different sensations after implanting such as in your voice, breathing, swallowing etc? The truth is they couldn’t have a truly double blind study by the very nature of the way the device works. Most every subject and/or patient when initially activated at .50mA or above relates having some voices changes, discomfort and/or swallowing difficulties each time the device activates. The point is one knows when they are initially activated.
5- At some point, I would also like to know your current settings?If there is anything we can share with you in terms of experiences and knowledge we’ve gained, it would be our pleasure to assist you. We don’t give advice. That you’ll have to pay for from the professionals but we do encourage you to empower yourself and actively participate in your goals toward wellness.
.
Posted by Ponder on September 10, 2003, at 16:10:48
In reply to Re: Another VNS study participant - To Ponder, posted by LifeTime on September 10, 2003, at 15:12:26
The "Therapy Factor" is very interesting. I believe at one point, they did change some other settings as opposed to increasing the amplitude. It is my impression that my amplitude setting is not the highest, but just a step down from that. I'll find out the actual numbers, thanks to your encouragement to do so.
To respond to your questions:
study site: University of Washington
date of implantation: Nov. 31, 2000
I was not in the placebo group.My next quarterly clinic visit is coming up on Monday. I'll have more info after that.
Although this is a minor thing, I will mention that I believe my surgeon did not leave quite enough length in the leads. At first they felt tight and somewhat restricting. They feel OK now, but the leads are quite visible. They look like a bulging vein. I was not advised of this possibility prior to the surgery, so although I was prepared for the unsightly bulge at the implantation site and the scar on my neck, I was not prepared for this rather visible effect.
When you're a single woman with a long history of psychiatric illness, you gotta protect what you've got going for you. My vanity causes me to repine for my previously more attractive appearance.
I find the voice alteration to be annoying. It distracts me while I am in conversation. (It's bad enough that others may not be listening while I talk; at least I should be paying attention.) I found some convenient small magnets that I am able to attach to my underclothing and turn the device off while on the phone, speaking in public, or engaged in an important conversation.
Posted by jerrympls on September 10, 2003, at 19:54:18
In reply to Re: Another VNS study participant - To Ponder » LifeTime, posted by Ponder on September 10, 2003, at 16:10:48
All--
I have much to say regarding previous posts and much to share - however, I am very tired from work....I plan to respond to comments eventually. I think my experiences will add some interesting things....
jerry
Posted by jerrympls on September 12, 2003, at 21:19:44
In reply to Re: Jerry, posted by LifeTime on September 8, 2003, at 0:55:28
> Dear Jerry,
>
> I’m not a regular reader of Dr. Bob’s website but I recently communicated with him about my wife’s favorable experience with the VNS and he directed me to this site.
>
> First, I am sorry that you did not find the device efficacious for your purposes and I do wish you a very speedy recovery from the explanting procedure. Before I give you and the other folks some information on our experiences I would appreciate if you could answer several questions for me.
>
> 1- What was the highest amplitude setting on your VNS that you ever attempted and over how many days did you leave that highest setting?THey never let me see the settings. I do know that the stimulation was on for 30 seconds every 5 mins. And at each setting they tried, they kept it there for 2-4 weeks - depending on my level of comfort.
>
> 2- When they explanted your VNS did they also remove the two coils around the vagal nerve or did they just clip the lead wires as close to the coils and left them in place?They removed EVERYTHING - chest implant and lead wire(s) and coils around the vegal nerve. The ENT doc I have is considered one of the best in the "business." He was involved with the epilepsy trials and surgeries and has dones hundreds of implantations and explantations. He did an excellent job - this time the surgery was a bit longer - about 3 hours - and the pain was a little more - but I'm healing very well.
>
> Your responses would be much appreciated. Incidentally, all the restrictions on the study participants have been removed. I am an active message board member on the Cyberonics website and I post under the name of “Herb.” I am a long time support person, caregiver, healthcare advocate and depression lay-expert to my wife as well as a former facilitator, board member, president of a local chapter of the DBSA and a state appointment as a Guardian Advocate.
>
> My spouse was implanted in December 1999 as part of the initial D-01 depression study. We have battled MDD (Major Depressive Disorder) some thirty-eight years. The road to achieving our goals has required a “trial and error approach” to wellness. To make a long story short, where Cyberonics did not allow any public communication from the study subjects and their support people, I formed collaboration privately with a number of recipients. This collaboration proved for us to be extremely beneficial.
>
> My wife is depression free and off all psychotropic medications for purposes of depression. Adding to the remarkable results is the fact that any situational and/or environmental stresses and/or upsets no longer have a lasting effect upon her mood. She simple gets over the event and carries on with her life. These events no longer cause her to spiral downward into severe depressive episodes.
>
> Her illness is controlled, stabilized and in remission. We are cautiously optimistic that after all these years we have achieved our goals of wellness and long-term remission of her illness. Another young woman with whom I communicate is also depression free without medications at higher settings. It has taken us time to achieve these results as we theorized that the higher amplitudes were the efficacious levels and we directed the researchers to follow our instructions and theorizes. In my wife’s case it took us some time to achieve those higher settings. We were already on our road to wellness when the failed D-02 study results were published and the CEO explained that the minimum settings for the protocol should have been 1.50 mA. We were above that setting, at that point in time, and therefore the reason for my question to you previously about your highest settings.
>
> Again, we are sorry you were not one of those being helped by the device but we do extend our very best wishes to you for wellness.
>
> Anyone interested in discussing the device might want to check out the Cyberonics message boards:
>
> http://www.vnstherapy.com/messagsfs.html
>
>
> Disclosure:
>
> Any one reading my posting please understand that I am a very long-term caregiver, support person and depression lay-expert to my spouse as well as a former DBSA facilitator, president, board member of a local chapter and a state appointment as a Guardian Advocate. I am not endorsing the use of any medication(s), treatment(s) and/or therapy(s). I am just trying to share some of our experiences, research, knowledge and readings over these many years in the hope it may benefit the reader. We have also greatly benefited in knowledge and friendship from the local support groups in our area including the DBSA (formerly the DMDA) and NAMI. Most importantly consult with a caring, compassionate and knowledgeable licensed healthcare professional.
>
>
> .
Posted by jerrympls on September 12, 2003, at 21:34:37
In reply to Re: Surgery tomorrow: removal of VNS implant, posted by LifeTime on September 9, 2003, at 10:54:12
> Dear Jerry,
>
> I am extremely glad to also read that you “have to run off to work.” To me, as a support person and caregiver, that is an extremely important and favorable sign. I do hope all continues to go well for you.
>
> 1- If you don’t mind, I would appreciate if you could also tell me which study site you were affiliated with?University of Minnesota
> 2- I presume that you were part of the D-02 double blind study?YES
> 3- Do you know if you were initially activated or were you part of the placebo group?
I think I was initially activated because one day I put a walkie-talkie up to my chest to see if it would cause any interference and the walkie-talkie DID give back interference. My brother who is an electrical engineer said that that would have mean that it was activated.
> 4- When you were activated, how did you actually know you were activated?When I was activated after the 3 mo. blind period, the doctor ramped it WAY up and it took my breath away and caused a huge tickle in my throat and made me cough. I must say - a couple hours after words I was in kind of a "high" mood - not manic - but kinda excited.
> 5- Did you experience any noticeable side effects?Side effects included (on the higher settings) voice alteration (sounded like my voice would go hoarse all the sudden), exasterbation of my asthma, and a slight tickle in my throat.
> 6- You mentioned, at first that you began to feel some relief and then it sort of stopped having a positive effect. Did you attempt any adjunctive treatments? If so, would care to share with us?
Approximately a couple weeks after they activated me - they kept it at a somewhat higher level - I could NOT feel it, but it was at a higher setting (they told me). Well, after a couple days my anxiety melted away and I had a brighter outlook on life - kinda overnight - nothing too drastic - but I did call my mother and tell her "I think it's working!" I noticed that I wasn't annoyed by little things that had annoyed me before, I wasn't so worried all the time and I had a slight improvement in my mood. However, after a week or so, it faded away. They tried to get it back with increased settings, but to no avail.
In between trying different settings, they docs would work on my meds. I was on a tricyclic + dexedrine, SSRI + Provigil, SSRI + Seroquel + Dexedrine + ativan and stayed on that for a long time. At one time they tried to add Topamax, but it didn't have good effects for me.
> 7- Was there any specific reason that prompted you to decided to explant the device?Biggest reason was the problems I had with it causing my asthma to worsen. When it would go off - especially in the winter - I would have stronger bronchial spasms. I would say I have a mild to severe case of asthma. So, I had it turned off for 3 months before explantation and my ashtma calmed down. I went into the hospital because my depression worsened (not due to the device being turned off in my opinion) and I started Nardil to which I repsonded MUCH better.
> 8- Did anyone make a recommendation to you to deactivate the device for a period of time and then try reactivating to see what happens?Yes, the study coordinator and the overseeing psychiatrists.
>
> Although we live in South Florida my wife’s doctor, Dr. Paul Goodnick was associated with the Univ. Of Miami School of Medicine and he was instrumental in helping to get her into the initial study at the Medical Univ. of South Carolina in Charleston. As part of the deal we had to agree to move to Charleston for three months during the acute phase of the study. We still continue to travel up to Charleston, on a quarterly basis, as part of our agreement. Until the FDA approves the device they remain responsible for her care.
>
> Your situation and case history is of much interest to me. I don’t me to pry into anything that you do not wish to divulge. As I indicated, the gag order has been removed and I have all along made a sincere effort to share our experiences, research and knowledge with a number of VNS study recipients as well as others that suffer MDD. Although my spouse is depression free I still continue my research, readings and collaborations as a backup and safety net, just in case. Her case history has been filled with numerous refractory episodes to various treatments so in a sense I personally can never quite get too comfortable and complacent.
>
> I look forward to your sharing you’re experiences and knowledge with us. Also, if you don’t mind, I would like to write to you personally. Is this acceptable to you and has you’re E-mail remained the same as listed on this message board?
>
> Once again, thanks for taking the time to share with us and our best wishes for your wellness.
>
> .
Sure, please email me anytime........
Posted by LifeTime on September 14, 2003, at 13:03:02
In reply to Re: Surgery tomorrow: removal of VNS implant » LifeTime, posted by jerrympls on September 12, 2003, at 21:34:37
Dear Jerry and Ponder,
I would first like to thank you both for taking the time to share with us your experiences. As you well know because of the suppressed communication during the study it was very difficult to obtain any information, added to the fact, no one really knows what an optimum setting is. As I’ve often mentioned, anyone attempting to treat the illness of major depression on a long-term basis will eventually learn that it is nothing more than a “trial and error approach” to wellness.
One of the difficulties I have as a support person is when I read ambiguous statements of fact such as Jerry indicated:
“…the doctor ramped it WAY up and it took my breath away and caused a huge tickle in my throat and made me cough.”
The problem is it lacks specific settings. When my wife was first activated they turned the device on at the default settings, one of which was the amplitude at .50 mA. We all noticed an immediate voice change but no detrimental side effects. Since she was depressed at the time and wanted to recover quickly so she pressed the researchers to increase the amplitude because she wanted to feel better as quickly as possible. At that time, they told us they had no information indicating that higher amplitudes were any more efficacious than the lower amplitudes. She insisted they raise the amplitude. They increased the amplitude to .75 mA and she responded by “hitting the roof” with jaw pain in the lower rear quadrant of her jaw. They lowered the setting back to .50 mA and we left the setting at that point for several months. The point I am trying to make is that .75 mA was intolerable for her to take initially and today she is at 2.25 mA without any side effects and depression free. I am only trying to emphasis the importance of being able to deal with precise information when discussing various treatment options. We really do not know what number it was for Jerry when “the doctor ramped it WAY up.”
As a support person, had I been one for you Jerry, I personally would have held off on the explanting option. But since that is neither here or there what is more important is a “Bravo” to you for advocating for your own wellness and taking as much control over you’re life’s decisions as possible. We wish you continued success and wellness with whatever treatment options you choose and we applaud you, once again, for advocating for your own wellness.
Ponder, I understand your concerns with vanity. My wife, Joyce, no longer brings up or discusses the incisions. The incisions were the least of her personally concerns. The neck incision kind of blends in with the natural folds of her neck although I can distinquish the sort of “looping” outline of the lead. The incision for the generator, above her left breast, is hardly noticeable. Joyce is petite and wears kind of skippy bathing suits but she doesn’t feel at all self-conscious about the surgical marks. I guess more important to her is the fact she is no longer depressed nor does she have any side-effects from device. She has no sensation whatsoever of the device cycling.Your idea of using the magnet when needing to speak for any length of time is a good one. The only time my wife uses the magnet, by taping it to her chest, is in the event of any medical procedures or when we want to check that the generator is still functioning. We insisted upon having the secondary or magnetic settings activated. These settings are set slightly higher so that if she swipes the magnet across the generator she gets enough of a jolt to know the battery is still working properly. She is approaching four years since her implantation and the last thing we want to happen is for the battery to die just after our quarterly visits to the researchers and her relapsing into depression because the device is not functioning.
Should anyone have any reason to discuss the VNS I shall continue to monitor this thread, the Cyberonics Message Board and/or if you list an E-mail address I shall gladly respond to you and share our experiences.
My very best wishes to you all for all the good you would wish for yourselves.
.
Posted by Ponder on September 16, 2003, at 16:51:11
In reply to Re: Another VNS study participant, posted by LifeTime on September 9, 2003, at 22:07:23
LifeTime,
Yesterday I requested the info on my VNS settings. They are:
Output Current: 1.25
Signal Frequency: 20
Pulse Width: 0250
Signal On: 30 sec.
Signal Off: 5.0 min.
Magnet Current: 0.00
Magnet on: 30
Magnet Pulse Width: 0130
I can see that your wife's output current is much higher and her on/off times differ significantly. It is encouraging to hear that she no longer even detects the stimulation. I guess I don't either except for the voice effects.As to the vanity thing, I am not bothered by the scars or even the bulge from the VNS unit. I'm bothered by the visible leads because I was not informed of this possibility. With all of the epilepsy patients who have had this device, I would think I'm not the first to have this and I feel (she says in a cranky tone) that I should have been advised of this.
If you have any comments on my settings based on your understanding of the device, I would be interested.
I think Jerry had to make the decision he did because of his asthma. Life is a series of trade-offs and uncertainties--especially, it seems, for consumers of psychiatric care.
Posted by jerrympls on September 16, 2003, at 18:48:28
In reply to VNS settings » LifeTime, posted by Ponder on September 16, 2003, at 16:51:11
> LifeTime,
> Yesterday I requested the info on my VNS settings. They are:
> Output Current: 1.25
> Signal Frequency: 20
> Pulse Width: 0250
> Signal On: 30 sec.
> Signal Off: 5.0 min.
> Magnet Current: 0.00
> Magnet on: 30
> Magnet Pulse Width: 0130
>
>
> I can see that your wife's output current is much higher and her on/off times differ significantly. It is encouraging to hear that she no longer even detects the stimulation. I guess I don't either except for the voice effects.
>
> As to the vanity thing, I am not bothered by the scars or even the bulge from the VNS unit. I'm bothered by the visible leads because I was not informed of this possibility. With all of the epilepsy patients who have had this device, I would think I'm not the first to have this and I feel (she says in a cranky tone) that I should have been advised of this.
>
> If you have any comments on my settings based on your understanding of the device, I would be interested.
>
> I think Jerry had to make the decision he did because of his asthma. Life is a series of trade-offs and uncertainties--especially, it seems, for consumers of psychiatric care.Yes, I had to do it because of my asthma. I've read that some people can get by without it effecting their asthma with different settings - unfortunately - we never found those settings.
Jerry
Posted by LifeTime on April 27, 2005, at 4:48:40
In reply to Re: Jerry, posted by LifeTime on September 8, 2003, at 0:55:28
For informational purposes:
I am a very long time support person and health care advocate for my wife, Joyce. My postings are somewhat different from most that you’ll find because I advocate for all treatment options, education of the patient and/or their support persons, un-coerced and informed medical decisions in collaboration with one’s trusted, compassionate, knowledgeable and licensed health care practitioner(s) and most importantly encouragement and hope, education and research.
I do not promote any medications, treatments or therapies but what I do is to share our experiences, research and education as well as collaborations with some of the front line researchers in a soon to be approved FDA new treatment option. I have worn amongst many hats, through the years, that of former local DBSA facilitator, board member, president and an appointment in my home state as a Guardian Advocate.
I have established a Website (http://www.vnsdepression.com) discussing and sharing experiences and our most recent odyssey into a new treatment option, VNS Therapy. As one gets to read my thoughts and my advocacy for wellness you’ll find I do not spend my time commiserating on TRD (Treatment Resistant Depression). I always advocate for hope, encouragement not to give up, education, research and although there is no cure for TRD, one can achieve control, stability and long-term remission.
If you have time, please read through the Website and then proceed on to the message forum and maybe we can share and instill hope for wellness for you and others.
I extend my best wishes to you for all the good you would wish for yourself and the others and a quick ascent toward wellness.
Warmly,
Herb
Posted by Bob on April 27, 2005, at 11:31:42
In reply to VNS (Vagus Nerve Stimulator), posted by LifeTime on April 27, 2005, at 4:48:40
I was under the impression that the FDA put an unexpected kibosh on the VNS, because they thought the response rate was not different enough from placebo. Have there been further developments?
This is the end of the thread.
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