Participant Experience: Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

[snow86]

The parts that you left out seem more important to me

"This subject however had chronic bilateral tinnitus (14 yr) that developed on awakening from neck surgery. Because tinnitus is highly heterogeneous in its presentation, it is unclear whether this therapy will be effective in other types of tinnitus such as noise-induced or drug-induced tinnitus, nontonal tinnitus, unilateral tinnitus, or in patients with moderate to severe hearing loss. Both animal and human studies will be needed to optimize the current therapy and to determine whether paired VNS therapy is effective in other forms of tinnitus."

I wonder why they chose such an uncommon patient if noise induced T and that other stuff written in bold is much more common and problematic.

 

[Sjoerd]

@snow86 , what is your point?

They do not know...! They would like to know.....

 

[snow86]

My point is in my last sentence! (above)
They could've picked a common T sufferer in the first place(noise induced, acoustic trauma etc.) and then report the results they get. This result you posted is somehow..vague?

But sure, im thankful that they're trying.
Seems like the VNS groupsaround de Ridder is making more progress than the guys in the US?

 

[labrat10687]

Just to let you know I will remain quiet about the VNS study until it is complete. I'm sorry but that is how it has to be. I understand your frustration.

 

[RaZaH]

making notch filter hearing aids would not be that complicated using phase reversal , same principle as noise cancelling hedphones. At least in theory.

 

[Silvio Sabo]

Case report April 2015:

http://journals.lww.com/otology-neu...trolled_Vagus_Nerve_Stimulation_Paired.1.aspx

The MML was reduced by 19 dB SL in the right ear (58 to 34 dB SL) and 9 dB SL in the left ear (39 to 30 dB SL) (Fig. 3). Before the sham stimulation period, the MML could not be obtained at baseline (>70 dB SL). After the sham therapy, the MML for the left ear was 22 dB SL and for the right ear 19 dB SL.

This looks pretty good

 

[Sjoerd]

My point is in my last sentence! (above)
They could've picked a common T sufferer in the first place(noise induced, acoustic trauma etc.) and then report the results they get. This result you posted is somehow..vague?

It is a valid question! But look on the bright side....they show reduction in tinnitus loudness etc etc. They show synchronization changes in parts of the brain related to tinnitus. They show that VNS can drive plastic changes in the brain....all these thins contribute to the statement of Michel Kilgard....."it might just be possible"

But sure, im thankful that they're trying.
Seems like the VNS groupsaround de Ridder is making more progress than the guys in the US?

I believe it is a collaboration....

 

[c0ldsun]

making notch filter hearing aids would not be that complicated using phase reversal , same principle as noise cancelling hedphones. At least in theory.

There is currently a trail on the way where they test hearing aids with notched filter:
https://clinicaltrials.gov/ct2/show/NCT02408575

 

[Sjoerd]

Just to let you know I will remain quiet about the VNS study until it is complete. I'm sorry but that is how it has to be. I understand your frustration.

Are you quiet about the study because it is requested of you or is it your own choice?

 

[BrStan@]

Are you quiet about the study because it is requested of you or is it your own choice?

It is has simply not effect on his T that is he going to remain silent. Its simple as that. I can not imagine myself with my severe T if i have a redaction from some new treatment i will remain quiet until the trial complete.

 

[Silvio Sabo]

It is has simply not effect on his T that is he going to remain silent. Its simple as that. I can not imagine myself with my severe T if i have a redaction from some new treatment i will remain quiet until the trial complete.

I would! You have to think about more then yourself. Having quality data in the trials is crucial. It's more important then screaming out off the top of your lungs that you have had good results. If the trials fail because the data is not valid then it effects every tinnitus sufferer alive today and future tinnitus sufferers.

Think one step further please.

 

[BrStan@]

I would! You have to think about more then yourself. Having quality data in the trials is crucial. It's more important then screaming out off the top of your lungs that you have had good results. If the trials fail because the data is not valid then it effects every tinnitus sufferer alive today and future tinnitus sufferers.

Think one step further please.

Silvio who am i to disagree with you. But he could post his own experience about the study i don't think he will compromise the final data, sharing his own experience. We are here all suffers we are not the one who run the trial and analysing the data and final results. Look for example the Autifony trial is on Phase II and we have participant experience posted, does that mean the whole trial screwed then?

 

[Silvio Sabo]

Silvio who am i to disagree with you. But he could post his own experience about the study i don't think he will compromise the final data, sharing his own experience. We are here all suffers we are not the one who run the trial and analysing the data and final results. Look for example the Autifony trial is on Phase II and we have participant experience posted, does that mean the whole trial screwed then?

Telling if he had good or bad results can screw with the data. If he says he has had good results then that might lead to others in the trial having good results due to the placebo effect opposed to the drug working. So therefore it is best to wait until the trial is over.

 

[Silvio Sabo]

There's also a lot of people in the AM-101 thread speculating as to if they are receiving the placebo or not based upon the viscosity of the drug and for how long they are feeling fullness in the ears. Indeed they are telling us about their experience but at the same time they are messing with the data. Stop doing that! If the people that are running the trial wanted you to know if you are getting placebo then what's the point of running a placebo controlled double blind study!?

 

[Nucleo]

There's also a lot of people in the AM-101 thread speculating as to if they are receiving the placebo or not based upon the viscosity of the drug and for how long they are feeling fullness in the ears. Indeed they are telling us about their experience but at the same time they are messing with the data. Stop doing that! If the people that are running the trial wanted you to know if you are getting placebo then what's the point of running a placebo controlled double blind study!?

Then it is up to the Sponsor company of the trial to have patients sign NDA's. If not then people can say whatever they want. In the end it does not affect the results.

 

[SoulStation]

Then it is up to the Sponsor company of the trial to have patients sign NDA's. If not then people can say whatever they want. In the end it does not affect the results.

But it could . As @Silvio Sabo pointed out- if they come on here and see others saying " I think its working- maybe .... " an see other people who got the same thing, this could sway their views IMO.

 

[Nucleo]

But it could . As @Silvio Sabo pointed out- if they come on here and see others saying " I think its working- maybe .... " an see other people who got the same thing, this could sway their views IMO

Except that the tinnitus loudness is ultimately measured by audiology. So barring any false reports in the minimum masking level assessment, it will not change the outcome of the results.

 

[labrat10687]

I would! You have to think about more then yourself. Having quality data in the trials is crucial. It's more important then screaming out off the top of your lungs that you have had good results. If the trials fail because the data is not valid then it effects every tinnitus sufferer alive today and future tinnitus sufferers.

Think one step further please.

This is a serious trial. I simply want the most accurate data possible. I do hope you understand that.

 

[SoulStation]

Except that the tinnitus loudness is ultimately measured by audiology. So barring any false reports in the minimum masking level assessment, it will not change the outcome of the results.

There are other assessments other then MML. Though I do agree with you on that. The MML would not change in the end. You are right in that.

 

[Silvio Sabo]

Except that the tinnitus loudness is ultimately measured by audiology. So barring any false reports in the minimum masking level assessment, it will not change the outcome of the results.

Yes, but figuring out who has placebo definitely would. By the way do you know what DOUBLE in "double blind" stands for?

It stands for that both the patients AND the doctors/nurses that are administering the drug are "in the blind". Meaning that the doctor who is giving you the drug has no clue if he is giving you sugar or the real deal. This is to ensure that they wouldn't treat their patients differently depending on whether they are receiving placebo or the real drug. This is made to ensure that ONLY the drug is responsible for any results.

Now if you go to that extent to ensure that you have good data. What good does it make when you have people running around and figuring out that they're getting the placebo or even worse figuring out that they're getting the real drug and then get results due to placebo effect!?

Also bear in mind that tinnitus is a highly subjective experience (hence the name subjective tinnitus). And our minds are capable of wonders.

 

[Nucleo]

Now if you go to that extent to ensure that you have good data. What good does it make when you have people running around and figuring out that they're getting the placebo or even worse figuring out that they're getting the real drug and then get results due to placebo effect!?

What good does it do? None. What harm can it do to the trial? None as well, since you will never know or be able to know for sure if you had the real deal or not.

I say let the people do whatever they want unless stated otherwise by the trial.

 

[Silvio Sabo]

What good does it do? None. What harm can it do to the trial? None as well, since you will never know or be able to know for sure if you had the real deal or not.

I say let the people do whatever they want unless stated otherwise by the trial.

You clearly have no training or experience in conducting medical trials or any scientific experiments.

 

[Nucleo]

You clearly have no training or experience in conducting medical trials or any scientific experiments.

Ok.

 

[LadyDi]

@labrat10687, I appreciate you letting us know you are still out there and involved in the trial. I personally am very interested in this technology. I look forward to your report when you can offer it.

I think it would be helpful, folks, if we not badger the witness.

 

[Silvio Sabo]

@labrat10687, I appreciate you letting us know you are still out there and involved in the trial. I personally am very interested in this technology. I look forward to your report when you can offer it.

I think it would be helpful, folks, if we not badger the witness.

I'm not badgering him. I'm supporting him in his decision not to say anything until the trial is over.

 

[LadyDi]

I'm not badgering him. I'm supporting him in his decision not to say anything until the trial is over.

Agreed. I was not referencing you.

 

[labrat10687]

To be sure if I was not taking part in this study I would want some info also. After this many years I'm tired of this tinnitus s****. It has really screwed my life up and I have had to make some very big changes in my life just to get to this point in time. We all want the very same thing. This is why when offered this(was very surprised!!)I went ahead with the surgery and decided to give this study my best effort.

I just feel the best way to handle this is for the study to get the best results possible from me and I have decided at this time not to talk about the results so far. I'm tired of the daily 2.5hr therapy and the doctor visits but it's what I agreed to. Only 30 people were selected and I consider myself very lucky. Very lucky. When I first got tinnitus all those years ago nothing like this was out there. Now it is. Remember the Belgium study had pretty good results so we know that this just might help many people. Have said before I do share your frustration.

 

[t-man]

I can agree with you. Frankly, if I were you, I'd just leave the thread until you were ready to share your results and experience in detail.

 

[Sjoerd]

This is a serious trial. I simply want the most accurate data possible. I do hope you understand that.

I do....but I think I can't resist asking If you are alive every once in a while....

 

[Sjoerd]

There are other assessments other then MML. Though I do agree with you on that. The MML would not change in the end. You are right in that.

Of course it will influence the MML (or at least we must assume that it will). We know that expensive placebo's are more effective than cheap placebo's. It is safe to assume that sharing results will offset the data. For that reason alone it is wise to not speak about it. So thumbs-up for @labrat10687

The reason that I am asking the "status" is simply: I would like to know if the trail is still running and if the "labrats" are still going strong!