New University of Michigan Tinnitus Discovery — Signal Timing

With 100 participants as opposed to the previously mentioned 400 participants, that is good news as it will take less time to sift through the data and write up the results for peer review.

Previous trial finish date was 31st July so they actually finished on the 6th July.

We might have news sooner than expected

 

So it's completed, however we don't know the results. Good surveillance though!

They enrolled 100 people, for some reason I had 400 people in my head.

 

Great to hear some optimism. But don't bet the farm on it!

I call to mind the worldy-wise @Toby1972 from der Fatherland who taught us a thing or two twelve months back.

 

It was 400. They reduced it in today's update to 100. Hopefully that is a positive sign.

 

I thought I was crazy. But I checked the change log. It says the number of participants didn't change...! I'm sure it said 400 in the planning.

 

Maybe you mean this: "The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals." from the "Study Description" paragraph on ClinicalTrials.gov study page.

 

@Padraigh Griffin, call me negative but I think that is a bad sign! Small groups can give better results. What happened to the other 300? Was it re-run after a disappointing trial with the larger cohort? God knows.

 

Could be indeed, but i thought the main table showed 400 participants too. This is the change log:

https://clinicaltrials.gov/ct2/history/NCT03621735?A=1&B=11&C=Side-by-Side#StudyPageTop

 

I could never comprehend how a small research team was going to do a 400 participant Phase 2 trial. That is a huge effort.

Speculation either way is irrelevant but one thing I would say is that it was ‘blinded’ so the decision to finish with 100 participants must have been made with FDA approval.

Now, it’s only a matter of time before results are out. A lot less time than if it was a 400 participant trial.

Here’s hoping the results are good.

 

I think one of the reasons the trial was smaller was because of COVID-19 and they only took people within close distance of the trial site.

 

This is the treatment I have been waiting for for so long. It says that the trial participants must be able to modify their tinnitus by touching their face. Is that going to be a requirement for this to work? Because nothing happens when I do that.

 

Could also be for the fact that there are not enough devices available, and only one location for all assessments. 2-3 visits a person for 400 participants equals 1200 actual days with one participant a day. That's impossible.

Either way 100 patients is enough. Let's be hopeful that the participants' tinnitus did not go up again after the treatment. Because if that is the case, a new trial is required to determine the protocol.

I read above that the results of Phase 1 are not impressive. Phase 1 is assessing safety and assessing the dosing. Efficacy is nice to have.

Phase 2 is purely about efficacy.

Phase 1 turned out very well. The treatment was found safe and it gave proper directions for the dosing as the treatment seemed to work towards the end (dosing=timeframe to use the device). That is what Phase 1 is about and in that sense mission accomplished. Needless to say I'm very hyped.

 

Or moving your jaw, sticking out your tongue, pulling the skin on your face. Really any physical movement that can change your tinnitus. That being said, Dr. Shore has stated previously that this doesn’t exclude the possibility that it may be effective on nonsommatic tinnitus as well. It just hasn’t been tested.

 

Ok, thank God. This is my last hope.

 

Study finds that sound plus electrical body stimulation has potential to treat chronic pain

Interesting. More benefits from bimodal stimulation. Shows this is really a good path to follow. The researcher is the man behind Lenire. Does not matter what you think about Lenire, he is an experienced scientist in this field.

 

Heck during her animal study she didn’t even bother asking the Guinea pigs if they could modulate their tinnitus and the tech worked for them

 

I'm sure they felt stigmatized and insulted over not being asked this critical question xD

 

Just look at these beautiful little machines

 

Did they fail? Are you joking? The results aren't even done being analyzed yet. The trial just officially ended yesterday. They will analyze the results, publish in a scientific journal, then depending on the results they will commercialize. What's so hard to understand about that?

 

The sample size of 20 was for Dr. Shore's 2017 study. The sample size for the trial that just ended yesterday was 100. That should give us a much better idea if the device works. The 2017 study had very positive results, that's encouraging, so let's hope that the results from the one that ended yesterday are as good or better than the 2017 study.

 

My god I hope none of them were triggered.

 

Design year 1990.

 

That’s when the study really started

 

Well brace yourselves: We'll find that the therapy works successfully for the ones for whom it works successfully.

The ones for whom it only works partially and the ones for whom it doesn't work much will be patiently back tapping our keyboards. But the knowledge base and science behind it all will have advanced.

 

Mazel mazel. Good things.

 

Hello,

Does anyone here know the volume (decibel) of the earbud during treatment?

I ask because I have somatosensory modulated tinnitus that I can either turn down or up so the protocol could help me but I also have hyperacusis.

Thanks.

 

200 dB.

They blast the tinnitus out of you.

 

In the prototype device we see only one ear bud.

But what about bilateral tinnitus (in both ears)? Do they intend to use then two earbuds or what?

 

Not sure if this was posted before, but here is a chart summarising Phase 1 Results that is easy to digest. I guess the ‘hope’ is that steep decline in tinnitus loudness can continue its downward trajectory with long term usage. In Phase 2 we will get an indication as the trial is two weeks longer.

 

I don’t understand how to read graph B where active treatment with washout is equal to sham. Doesn’t it suggest the improvement was short term only and then it got almost to baseline?