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.
.
poster:LifeTime
thread:255190
URL: http://www.dr-bob.org/babble/20030907/msgs/258814.html