New University of Michigan Tinnitus Discovery — Signal Timing

[Flyingsheep]

I'm just wondering if anyone else is going to take part in this trial?

I sent an email two weeks ago and no response yet.

 

[Jimmyboi]

I have just received notification from the University of Michigan that recruitment for a second trial for subjective tinnitus is now underway which I have enrolled.

I'm just wondering if anyone else is going to take part in this trial?

The concept is exciting. I hope it really works.

Good job man!

I hope you a silence filled future.

I'm sure you'll have to sign an NDA but let us know of your experience whenever you can

 

[Paul Walter]

Well I just received my consent form and Zoom interview from University of Michigan.

I'm sorry to report that I was contacted by the university and was told I may be suitable.

As it turns out this trial is a follow-up to the initial trial and only caters for those that can somatically alter their tinnitus by clenching the jaw. Additionally, one must have only had tinnitus for up to 6 months and have no hearing loss.

So I guess the majority of us will continue to wait and hope.

 

[DaveFromChicago]

To Paul Walter:

Thanks very much for the report. It mentions almost exactly the previous, absurdly narrow stipulations for Trial Acceptance.

Am I to understand that since there have been from the outset a nonvarying set of such narrow requirements, it will only be theoretically beneficial to that very small fraction of tinnitus patients who conform to these?

Someone should e-mail Susan Shore for a clarification.

My confidence in this device recedes according to each new report about it.

 

[AfroSnowman]

To Paul Walter:

Thanks very much for the report. It mentions almost exactly the previous, absurdly narrow stipulations for Trial Acceptance.

Am I to understand that since there have been from the outset a nonvarying set of such narrow requirements, it will only be theoretically beneficial to that very small fraction of tinnitus patients who conform to these?

Someone should e-mail Susan Shore for a clarification.

My confidence in this device recedes according to each new report about it.

I am more bullish on this than some others. I think nothing has changed about the potential of Dr. Shore's device from the time that it was generating a lot of excitement except for the year's delay due to COVID-19.

I suspect, without any special knowledge, that Dr. Shore is looking at all this through the eyes of a life long academic researcher. She has built her career and reputation on solid research and writing papers that are argued and picked over by other academics. When I was an academic researcher, in a different field many long years ago, the coin of the realm was publications. It was absolutely critical that you built your experiment to survive all criticism and challenge, make it as tight and bulletproof as possible.

This is what I think she is doing with this narrow and slow pace of the study. I think that she is looking to narrowly but definitively prove or disprove that her theory works. I would imagine that the narrower the group you are studying, the easier it is to control for variables that might confuse the results.

I likewise think this is why she appears from a tinnitus sufferer's perspective to not be in a big hurry. I think her primary day to day goal is to have a perfect study. I am sure she is interested in the commercialization and the eventual impact on lives that her discovery will have but when the focus of your entire career for decades has been the quality of your research and you are at a point of your career where you call your own shots, you are still probably focused on that.

 

[Tomas80]

I am more bullish on this than some others. I think nothing has changed about the potential of Dr. Shore's device from the time that it was generating a lot of excitement except for the year's delay due to COVID-19.

I suspect, without any special knowledge, that Dr. Shore is looking at all this through the eyes of a life long academic researcher. She has built her career and reputation on solid research and writing papers that are argued and picked over by other academics. When I was an academic researcher, in a different field many long years ago, the coin of the realm was publications. It was absolutely critical that you built your experiment to survive all criticism and challenge, make it as tight and bulletproof as possible.

This is what I think she is doing with this narrow and slow pace of the study. I think that she is looking to narrowly but definitively prove or disprove that her theory works. I would imagine that the narrower the group you are studying, the easier it is to control for variables that might confuse the results.

I likewise think this is why she appears from a tinnitus sufferer's perspective to not be in a big hurry. I think her primary day to day goal is to have a perfect study. I am sure she is interested in the commercialization and the eventual impact on lives that her discovery will have but when the focus of your entire career for decades has been the quality of your research and you are at a point of your career where you call your own shots, you are still probably focused on that.

If the treatment is to last 6 weeks, the treatment cycle could be tried many times each year. For example, in guinea pigs. In all those years of research, only two trials on people have been carried out. I can't understand so many years of research.

Only data can bring progress. And the data comes from a trial. More trials = more data = more progress.

 

[AfroSnowman]

If the treatment is to last 6 weeks, the treatment cycle could be tried many times each year. For example, in guinea pigs. In all those years of research, only two trials on people have been carried out. I can't understand so many years of research.

Only data can bring progress. And the data comes from a trial. More trials = more data = more progress.

She is doing trials right now. I think this one is supposed to have a couple hundred participants. I know the Phase 1 trial was a 6-week cycle. Have you read that they are only doing 6 weeks in this one? In addition I imagine different treatment modalities are being tested.

I think the alternative model is Lenire which got a 3 (I think) low quality studies done quickly (i.e. no control group, no placebo, no sub typing, minimal variants on treatment protocols). This led to an underwhelming product and some reports of harm.

Of course I don't want this to take a day longer than it needs to take, but this is a university study, not a private company which means the drivers are different. It also means that when/if it comes out we can have a much greater confidence that it will work as advertised.

My original point is that we were really excited about this 2 years ago for good reason. We expected the study to be completed late last year and to be aggressively moving to market now. The only thing that has changed in the meantime is a one year delay due to COVID-19. No new bad data came out, no new studies indicating that this methodology is flawed. The only thing that changed is COVID-19. I just think there is no reason to believe that her study won't be completed at the end of the year and if it confirms/improves on the first one that it will be moving toward the marketplace in 2022.

 

[Jimmyboi]

Of course I don't want this to take a day longer than it needs to take, but this is a university study, not a private company which means the drivers are different. It also means that when/if it comes out we can have a much greater confidence that it will work as advertised.

Working at a University myself, it's very true they push for papers to be submitted to journals and strong research backgrounds with enterprise income being a nice secondary outcome.

I have no idea who calls the shots in the case of UMICH but it's a shame they don't run parallel trials across multiple university sites, seems to be far more common in the EU for several Universities to all contribute to some research.

 

[Jrblovsky]

To Paul Walter:

Thanks very much for the report. It mentions almost exactly the previous, absurdly narrow stipulations for Trial Acceptance.

Am I to understand that since there have been from the outset a nonvarying set of such narrow requirements, it will only be theoretically beneficial to that very small fraction of tinnitus patients who conform to these?

Someone should e-mail Susan Shore for a clarification.

My confidence in this device recedes according to each new report about it.

You shouldn't have any confidence at all. It's going to to be a bust just like Lenire. The research she is doing is interesting but the device they are peddling will never result in anything that provides results. If it did, they would be accepting literally anyone with hearing loss.

 

[DaveFromChicago]

To Jrblovsky:

My sentiments exactly. I recall that our Chicago Tribune in their Health and Wellness section had an article about this in early January 2018, which means that clinical trials were first undertaken in 2017. We now have the trial completion date extended into 2022. Every year there are extensions into the next, which results in less confidence that I have in its effectiveness.

 

[Jrblovsky]

My sentiments exactly. I recall that our Chicago Tribune in their Health and Wellness section had an article about this in early January 2018, which means that clinical trials were first undertaken in 2017. We now have the trial completion date extended into 2022. Every year there are extensions into the next, which results in less confidence that I have in its effectiveness.

Yep. These devices are worthless in my opinion. If you have been researching a topic for over 20 years and have literally nothing to show for it, there is a reason. The stuff is interesting but it seems a slim to zero margin it will actually help. It's going to be a bust like I said, just like Lenire. Dr. Shore's research talks about a lot of interesting things but it does nothing for us suffering life altering consequences.

 

[John Mahan]

She is doing trials right now. I think this one is supposed to have a couple hundred participants. I know the Phase 1 trial was a 6-week cycle. Have you read that they are only doing 6 weeks in this one? In addition I imagine different treatment modalities are being tested.

I think the alternative model is Lenire which got a 3 (I think) low quality studies done quickly (i.e. no control group, no placebo, no sub typing, minimal variants on treatment protocols). This led to an underwhelming product and some reports of harm.

Of course I don't want this to take a day longer than it needs to take, but this is a university study, not a private company which means the drivers are different. It also means that when/if it comes out we can have a much greater confidence that it will work as advertised.

My original point is that we were really excited about this 2 years ago for good reason. We expected the study to be completed late last year and to be aggressively moving to market now. The only thing that has changed in the meantime is a one year delay due to COVID-19. No new bad data came out, no new studies indicating that this methodology is flawed. The only thing that changed is COVID-19. I just think there is no reason to believe that her study won't be completed at the end of the year and if it confirms/improves on the first one that it will be moving toward the marketplace in 2022.

I like positivity. In fact, positivity has to be the cornerstone of how we cope with tinnitus. We have to on some level accept it. Perhaps not a friend but as part of our being. Resistance is futile and can cause mental illness. It took me a couple of years to come to better terms with mine which is quite variable. Mine is somatically based but can be quite loud depending on sleep and brain wave patterns due to the types of dreams I have.

But, we part ways on your optimism about the Shore device. Lenire is a close analog albeit perhaps more crude and hasty in its implementation and rush to market. Its efficacy is poor.
Now you may think as a scientist... I am as well... that the devil is in the details. Closely correlate machine settings to the particular candidate and success right? No. Reason is, tinnitus is too multi variant. No two people have the same triggers for their tinnitus. We are like snow flakes or fingerprints.

You reference Shore tightening standards for test to improve the reliability of trial testing. You interpret this as a positive. But, even if the trial is successful, it denies perhaps a much greater population of tinnitus sufferers. They are excluded from being helped. Might Shore's device help those that don't precisely qualify for her trial? Maybe but likely not. You don't believe that Susan Shore or her staff hasn't studied the Lenire device in close detail? Of course she/they have. So Shore's device application would end up being no different than the crude analog and tuning of the Lenire device. This is for the simple reason that the study is based upon 'perceived' compatibility between test subject and the device and why the narrow standard of who they are trialing. Shore is hunting for this precise nexus. And then... there are those where the Lenire device caused greater assault... increased volume of tinnitus. The unthinkable. Does this not have relevance to the Shore device as well when she doesn't get subject qualifications for her device just right... the nexus she is searching for?

No, I believe the Shore is a wild goose chase in the interest of science. Sure signal timing has veracity in terms of the brain recognizing tinnitus. But bending the arc based upon the difference in neuroplasticity of each of us... revising the brain's recognition of the tinnitus signal for each of us precisely, is a bridge too far... unless you hit the signal timing lottery which perhaps some have by using the Lenire device. What is this percentage of people? But do you want to be tinkered with and take this chance, based upon a very narrow range of test parameters which may not and likely don't closely coincide with your particular modality of tinnitus? Only if you are a gambling man... presuming you are male.

I hold out for hair cell regrowth... or Elon Musk's Neuralink to kill the excitation in the brain... or quell it. Implementation of Neuralink in the context of tinnitus would require a technology that can precisely identify what region of the brain is firing creating the aberrant noise in the auditory cortex. I don't think there is enough rigor in the Shore device test protocol to precisely coincide with the individuality of each of our particular type of tinnitus. And moreover, this narrow group of tinnitus sufferers doesn't encompass the much broader group of those that suffer with tinnitus. Let's say the Lenire device is crude. Shore's device would only end up being slightly less crude and therefore only applicable to a very narrow range of sufferers... and then there would still have to be luck involved.

This device isn't a slam dunk or it would have been implemented by now. Suffering is too great throughout the world. A pandemic of mental illness caused by tinnitus. It is an academic exercise to learn more about how a small subset of somatic tinnitus sufferers respond to change in signal timing. My opinion of course.

 

[GBB]

Yep. These devices are worthless in my opinion. If you have been researching a topic for over 20 years and have literally nothing to show for it, there is a reason. The stuff is interesting but it seems a slim to zero margin it will actually help. It's going to be a bust like I said, just like Lenire. Dr. Shore's research talks about a lot of interesting things but it does nothing for us suffering life altering consequences.

I hope not - my tinnitus came on after noise but sometimes I wonder if my brain is damaged. If that's the case hearing regex won't help me - I need something that acts on the brain.

 

[Jrblovsky]

I hope not - my tinnitus came on after noise but sometimes I wonder if my brain is damaged. If that's the case hearing regex won't help me - I need something that acts on the brain.

I'm sure you have hearing loss like everyone else on this board. The only way I would say brain injury is if you were exposed to a blast trauma. Those can cause that.

 

[Jimmyboi]

I'm sure you have hearing loss like everyone else on this board. The only way I would say brain injury is if you were exposed to a blast trauma. Those can cause that.

Considering the massive variety of ways people seem to begin experiencing tinnitus this seems pretty reductionist.

Reminding everyone once again that someone in this thread was in the previous trial and had their tinnitus essentially eliminated it feels unfair to write off the whole area of research into reducing tinnitus symptoms in patients within normal hearing ranges.

The argument of tinnitus is entirely linked to some kind of hearing loss and everyone has some kind of hearing loss dodges the straightforward conclusion of why don't a hell of a lot more people have moderate and above tinnitus?

 

[Keith Handy]

The argument of tinnitus is entirely linked to some kind of hearing loss and everyone has some kind of hearing loss dodges the straightforward conclusion of why don't a hell of a lot more people have moderate and above tinnitus?

I don't think this argument is made to dodge a question. Obviously there are neurological differences at play. The hope is that with hearing restoration, even on "good" ears that score well on an audiogram, hidden/subtle missing frequencies will no longer provide the nervous system a reason to generate a false signal at those frequencies, and even those who are neurologically susceptible might find relief sooner, as fixing the hearing is in closer reach than fixing the nerves/brain.

 

[Jimmyboi]

I don't think this argument is made to dodge a question. Obviously there are neurological differences at play. The hope is that with hearing restoration, even on "good" ears that score well on an audiogram, hidden/subtle missing frequencies will no longer provide the nervous system a reason to generate a false signal at those frequencies, and even those who are neurologically susceptible might find relief sooner, as fixing the hearing is in closer reach than fixing the nerves/brain.

I'm all for this kind of hope and if some kind of hearing regenaration becomes available first I would like to try it even with audiologists and ENT's telling me my hearing is near perfect. If that works I'd be over the moon, so I'm certainly not saying we shouldn't try that if it's an option available to us.

The only issue I take is when other methods of potentially mitigating tinnitus that don't focus on hearing loss are written off completely with the argument that those who have normal hearing must have hidden hearing loss, even the NHS notes 1/3 people with tinnitus have normal hearing. Could this all be attributed to hidden hearing loss? Maybe, we just don't know enough.

I prefer positivity in the idea there are many avenues through which people are attempting to mitigate tinnitus, we're all here because we're struggling and we don't need excess stress from constant negative news when really the research to date by Dr Shore (although painfully slow) has been exceedingly positive.

 

[Rb86]

I am more bullish on this than some others. I think nothing has changed about the potential of Dr. Shore's device from the time that it was generating a lot of excitement except for the year's delay due to COVID-19.

I suspect, without any special knowledge, that Dr. Shore is looking at all this through the eyes of a life long academic researcher. She has built her career and reputation on solid research and writing papers that are argued and picked over by other academics. When I was an academic researcher, in a different field many long years ago, the coin of the realm was publications. It was absolutely critical that you built your experiment to survive all criticism and challenge, make it as tight and bulletproof as possible.

This is what I think she is doing with this narrow and slow pace of the study. I think that she is looking to narrowly but definitively prove or disprove that her theory works. I would imagine that the narrower the group you are studying, the easier it is to control for variables that might confuse the results.

I likewise think this is why she appears from a tinnitus sufferer's perspective to not be in a big hurry. I think her primary day to day goal is to have a perfect study. I am sure she is interested in the commercialization and the eventual impact on lives that her discovery will have but when the focus of your entire career for decades has been the quality of your research and you are at a point of your career where you call your own shots, you are still probably focused on that.

She's doing a disservice to the entire tinnitus community if she is squandering time and funding to prove some narrow theory.

The entire point of research is to learn, and gain data. Failure is a great teacher.

She needs to commit to the cause, and not the vanity of being right.

 

[AfroSnowman]

She's doing a disservice to the entire tinnitus community if she is squandering time and funding to prove some narrow theory.

The entire point of research is to learn, and gain data. Failure is a great teacher.

She needs to commit to the cause, and not the vanity of being right.

I mean the alternative can be found in the Lenire thread. A lot of people were angry that they felt that they were essentially using customers as a Phase 3 trial. The result was poor results for most, worsening for some, $2000 out of pocket plus travel for all who tried.

We will see maybe what she has is worthless, maybe it will be a game changer for some of us, but it takes time to roll out effective, safe, well vetted treatments. What she has now is still an experimental treatment. Messing with the brain and auditory system probably shouldn't be done lightly. In addition for all I know (and I know nothing about this process, though I suspect this to be the case), she doesn't have enough data to get FDA approval in which case she couldn't bring it to market without this additional study so the question is mute. I do know that prior to COVID-19 she was interviewed about having the study completed at the end of 2020 and planning to rapidly bringing it to market. COVID-19 set it back a year, COVID-19 sucks.

I fervently hope that brilliant results emerge at the end of the year and that a treatment will be commercially available soon after.

 

[MRItechssuck]

FWIW I was told the 100 mile radius is still in effect for the latest trial, unfortunately.

I check in from time to time, and just like I thought... more disappointments than successes...

Good luck to all.

 

[Paul Walter]

This has probably been asked before but is Susan Shore's tinnitus treatment in anyway different than Neuromod's Lenire treatment?

I understand one stimulates the tongue and the other the vagus nerve on the back of the neck but what is the difference here?

I just hope they are both successful. I can't take this any more.

 

[Tezcatlipoca]

This has probably been asked before but is Susan Shore's tinnitus treatment in anyway different than Neuromod's Lenire treatment?

In my opinion no, and Lenire is already out and showed no results.

 

[Jrblovsky]

Dr. Shore's device should be written off like Lenire. It's not going to work either.

 

[F-u-T]

I have read a lot about Neuromod's trial data and also Dr. Shore's trial data. The biggest differences I have noticed other than area of stimulation was the stimulation timing settings. Lenire's timing settings did not appear to use any of the same settings that Dr. Shore has published that resulted in improvements. I think she may have patents on her research settings so maybe that is why Lenire was not using the same ones from what I could tell. That's why I still have hope for Dr. Shore's device and would not take a chance on Lenire making my tinnitus worse.

The speed at which Dr. Shore's device is moving along is Fu@#ing maddening though!

 

[Jimmyboi]

Dr. Shore's device should be written off like Lenire. It's not going to work either.

Once again reminding you that Dr. Shore's device has worked on people in this very thread and the data Susan Shore has released so far is promising.

Maybe it won't work, but you definitely don't know that.

 

[Jimmyboi]

This has probably been asked before but is Susan Shore's tinnitus treatment in anyway different than Neuromod's Lenire treatment?

In my opinion no, and Lenire is already out and showed no results.

Susan Shore's device targets somatic tinnitus on the muscles that allow the patient to modulate their tinnitus.

We obviously haven't seen the finished device, but the trials so far have set the frequency and timing of the sounds/electrical charge with the help of an EEG that tested which combination saw some response in the brain.

Lenire aimed through the tongue only and many people have questioned its use of signal timing.

There is a pretty substantial difference between these devices hence why many are waiting to see what these Phase 3 trials uncover.

 

[Jimmyboi]

I didnt mean to post this much in a row but I hadn't seen anyone else mention this yet.

Did some poking around to see what state her trials are in and saw a name for the device I hadn't come across before.

https://clinicaltrials.gov/ct2/show/NCT03621735

"Intervention/treatment
...
Other Name: St. Jude Medical Invisible Trial System"

Which a quick Google shows this.
https://www.neuromodulation.abbott/...-jude-medical-invisible-trial-system-scs.html

Looks like that move towards commercialisation could be adapting a pre existing device?

 

[Sironketchup]

Hey guys,

Does anyone know if Dr. Shore's device is stimulating the vagus nerve as well?

If yes, this might be a missing link why Lenire does not work that well.

I'm thinking of combining Lenire with tVNS. Any thoughts?

Cheers!

 

[Spiral]

Yep. These devices are worthless in my opinion. If you have been researching a topic for over 20 years and have literally nothing to show for it, there is a reason. The stuff is interesting but it seems a slim to zero margin it will actually help. It's going to be a bust like I said, just like Lenire. Dr. Shore's research talks about a lot of interesting things but it does nothing for us suffering life altering consequences.

I mean, more research isn't such a bad thing. We all know how Lenire turned out. Even if she isn't able to make a decent commercialized product, at least she'll have the research and we'll have a greater understanding so that when someone does get close to making something worthwhile they won't make the same mistake. At this point, there's no reason not to let her do the research even if it will take potentially years.

 

[AfroSnowman]

Does anyone know if they use a standard audiogram or an extended for their device?