New University of Michigan Tinnitus Discovery — Signal Timing

[Harder Calm]

How do they know it worked on guinea pigs? Let me guess, the guinea pigs were more happy in life.

If I understood correctly, both by disturbed behavior (and being less distressed after treatment) as well as brain scans.

 

[UKBloke]

I would imagine those of us who have a barrage of different tones will need to start with the easiest one to match and try to remove/reduce them one-by-one... pulling the curtain back on each one so to speak.

I have a dominant high-pitch intrusive frequency plus barrage of other stuff. The barrage of other stuff I was habituated to for 25 years and it was honestly not problematic at all (habituation first time round took about 2-3 years).

Pure speculation, but it may be the case that this device only needs to tackle a single dominant frequency for natural habituation to anything that may remain being much easier for people.

 

[IntotheBlue03]

I have a dominant high-pitch intrusive frequency plus barrage of other stuff. The barrage of other stuff I was habituated to for 25 years and it was honestly not problematic at all (habituation first time round took about 2-3 years).

Pure speculation, but it may be the case that this device only needs to tackle a single dominant frequency for natural habituation to anything that may remain being much easier for people.

Hi all,

I'm posting the lab clinician's response that I'm still trying to decipher as a layman.

Please feel free to offer your input but at a least from what I gather it seems he was more confident that the focus on the DCN as the driver of tinnitus activity was more significant to benefiting users than the pitch match, tone or cause of tinnitus. Again I realize this was a very oversimplified response.

 

[AfroSnowman]

Phase 1 had 12/20 patients (60%) benefitting.

I've having trouble finding that data line in her study. All I see are aggregated data in the paper. Can you point me to the 60% benefitting citation?

 

[kingsfan]

I've having trouble finding that data line in her study. All I see are aggregated data in the paper. Can you point me to the 60% benefitting citation?

I just read an article from 2018 where they stated out of a study of 20 people, 2 had complete elimination and 11 had reduction.

Source:
[DailyMail.co.uk] Do YOU suffer from tinnitus? Study reveals 'resetting' brain cells using electric currents can alleviate the misery of phantom sounds

 

[LGuapo]

I'm posting the lab clinicians response that I'm still trying to decipher as a layman.

Please feel free to offer your input but at a least from what I gather it seems he was more confident that the focus on the DCN as the driver of tinnitus activity was more significant to benefiting users than the pitch match, tone or cause of tinnitus. Again I realize this a very oversimplified response.

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As someone with a piercing tinnitus tone above 12 kHz, I'm disappointed that their device only goes that high. I appreciate that they're hopeful that it will help those with higher pitched tones, but the fact that they do tone matching at all tells me it's likely an important factor.

I don't understand why they say producing tones above 12 kHz is difficult, though. In my experience in the audio field, producing low frequencies is much more of a challenge than high. I can understand why hearing aids don't function at high frequencies, since there is need for feedback and echo cancellation. But in this case, I'd think it would just be a straight forward case of sound generation.

 

[Mathew Gould]

I just read an article from 2018 where they stated out of a study of 20 people, 2 had complete elimination and 11 had reduction.

Source:
[DailyMail.co.uk] Do YOU suffer from tinnitus? Study reveals 'resetting' brain cells using electric currents can alleviate the misery of phantom sounds

So only 60% of people benefited from the device in the small trial? Seems low... Any trials after that which had a higher benefiting rate?

 

[AfroSnowman]

So only 60% of people benefited from the device in the small trial? Seems low... Any trials after that which had a higher benefiting rate?

That was the only human trial other than the one that is ongoing.

 

[Mathew Gould]

That was the only human trial other than the one that is ongoing.

60% of people improving doesn't seem too promising to me. I thought almost everyone had their tinnitus reduced in half... I read that on here before.

 

[AfroSnowman]

60% of people improving doesn't seem too promising to me. I thought almost everyone had their tinnitus reduced in half... I read that on here before.

I guess we'll find out in a few months. 60% is exactly 60% more than what we have now.

That being said I'd love to see the individual results. Does anyone know where that info exists? It must be in a presentation somewhere. I mean it was only 20 folks, it could easily fit on a single scatter plot.

I wonder if that 60% represents those with statistically significant reduction but maybe smaller improvements were evident in others.

I thought having read through the paper that the 12 dB reeducation was an average across the groups. Does that mean that 40% had no reduction but those that did respond have an even greater than 12 dB response?

In the end this is all just conjecture to pass the time until we get some real answers later this year.

 

[Survivor234]

60% of people improving doesn't seem too promising to me. I thought almost everyone had their tinnitus reduced in half... I read that on here before.

You should note that whether you get any sort of reduction or not depends on the amount of time you spend using the device. For some, they see results immediately after using it while, for others, it takes several weeks. The trial in question was only for four weeks. This new trial I believe goes up to six weeks of use.

I think that, considering the variance in the amount of time you need to use the device, it is possible that it takes some time for your neurons to be reset. And the amount of time may differ depending on each individual's tinnitus, age, pitch, etc.

 

[IntotheBlue03]

Hi all,

For those well versed in the science, do any of you know if "somatic" tinnitus also accounts for neurological based tinnitus (autoimmune like MS, noise induced)? I believe I had seen the stat somewhere on the boards that referenced 80% of tinnitus sufferers can modulate somatically, so I'd assume that could include some neurological sufferers as well for this device?

@Survivor234, correct me if I'm wrong but I thought you had inquired about this for users who are noise induced/neurological but cannot modulate their tinnitus?

Again I know all this is speculation just looking for insight from folks for questions that linger in a tortured mind.

 

[Bjjwal]

I just read an article from 2018 where they stated out of a study of 20 people, 2 had complete elimination and 11 had reduction.

This is already starting to sound like Lenire 2.0...

 

[NYCGuy]

This is already starting to sound like Lenire 2.0...

Please don't compare Susan Shore to Lenire. Susan has been studying tinnitus for 20 years and she is really trying to helps us. Lenire only cares about making money, they didn't even do a real clinical trial like Susan Shore is doing.

 

[Bjjwal]

Please don't compare Susan Shore to Lenire. Susan has been studying tinnitus for 20 years and she is really trying to helps us. Lenire only cares about making money, they didn't even do a real clinical trial like Susan Shore is doing.

I'm not saying that Susan Shore isn't trying to help people. The fact that she responds to people's emails so quickly shows to me that she does care.

But seriously, how many million dollars in funding and the best we can get is a 20 person study with only 11 showing ANY improvement? That doesn't sound any better than Lenire's numbers.

I really hope that Shore has been able to refine the efficacy of her device over the last few years, otherwise I see the crash of a huge hype train and a lot of disappointed people.

 

[Bjjwal]

I thought having read through the paper that the 12 dB reeducation was an average across the groups. Does that mean that 40% had no reduction but those that did respond have an even greater than 12 dB response?

This is what I thought as well.

 

[kingsfan]

60% of people improving doesn't seem too promising to me. I thought almost everyone had their tinnitus reduced in half... I read that on here before.

Well it's 65% if that helps.

 

[NYCGuy]

I'm not saying that Susan Shore isn't trying to help people. The fact that she responds to people's emails so quickly shows to me that she does care.

But seriously, how many million dollars in funding and the best we can get is a 20 person study with only 11 showing ANY improvement? That doesn't sound any better than Lenire's numbers.

I really hope that Shore has been able to refine the efficacy of her device over the last few years, otherwise I see the crash of a huge hype train and a lot of disappointed people.

A clinical trial is going on at the moment with 400 participants, source:

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

 

[Bjjwal]

A clinical trial is going on at the moment with 400 participants, source:

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

Thanks for the link!

 

[GlennS]

Just looking at the ClinicalTrials site and noticed some differences in the current study vs the old one. Aside from the much higher participant numbers (400 vs 20), this round is testing 6 weeks of treatment vs 4 weeks previously and is testing both 30 and 60 minutes treatments vs just 30 minutes previously.
84 days till April.

IMHO, the small sample-size is one reason why I would not join those who already claimed matter-of-factly that this thing was already proven to work. This new trial should be much more definitive.

 

[GlennS]

60% of people improving doesn't seem too promising to me. I thought almost everyone had their tinnitus reduced in half... I read that on here before.

As learned through Lenire, the most important factor is what constitutes "improvement". If it's barely "statistically significant" then it's little better than placebo.

 

[OptimusPrimed]

As learned through Lenire, the most important factor is what constitutes "improvement". If it's barely "statistically significant" then it's little better than placebo.

While you're not entirely wrong; we don't have any other options right now so barely statistically significant is better than nothing.

Electrical stimulation is the most effective treatment for tinnitus to date, be it cochlear implantation or iterative electrical stimulation. I see this device as in the iterative category and it could bring some relief.

 

[AfroSnowman]

As learned through Lenire, the most important factor is what constitutes "improvement". If it's barely "statistically significant" then it's little better than placebo.

And with Lenire the lack of a control makes the whole question of change beyond placebo impossible to discern.

 

[PeterPan]

As learned through Lenire, the most important factor is what constitutes "improvement". If it's barely "statistically significant" then it's little better than placebo.

Neuromod have stated that 86% of participants who undertook the treatment in their trial saw an improvement. This stat only has meaning if all the participants in this 86% had a significant difference from a control that was above the MCID for the scale they used (which they didn't) and there was a control (which there wasn't!, or at least there wasn't an arm which they stated was a control in advance).

MCID - Minimal clinically important difference

 

[IntotheBlue03]

So after crisscrossing the research threads I have to ask some of the senior folks who know better than me, is Dr. Shore's device the only device we have with the potential for release and treatment in 2022?

@AfroSnowman, @OptimusPrimed, @DebInAustralia, @linearb, @GlennS, @Lukee.

 

[Survivor234]

@IntotheBlue03, you should also keep an eye on Johnson and Johnson's new drug. It looks like the big-wigs are starting to pay attention to us.

 

[IntotheBlue03]

Thanks @Survivor234, definitely watching the pharma space (I actually work at Merck but not in the research end) but looks like nothing populating in 2022 outside of Susan's potential release I assume?

 

[AfroSnowman]

So after crisscrossing the research threads I have to ask some of the senior folks who know better than me, is Dr. Shore's device the only device we have with the potential for release and treatment in 2022?

@AfroSnowman, @OptimusPrimed, @DebInAustralia, @linearb, @GlennS, @Lukee.

Whether this is available in 2022 or not is something we don't know yet, but it is the only treatment I know that is this promising that even has a chance of becoming available in 2022.

For what it is worth I'd be surprised to see this in our hands in 2022 (will it be confirmed safe and effective in the current trial, ending in April, how quickly does the FDA approve it once the data is in, and how quickly it can be manufactured and put into the audiologist distribution chain?) but if everything goes well I would not be shocked to see it become widely available in 2023.

 

[Jason Ranovik]

Just FYI, the recruitment for the Phase II trial is now closed (and has been for a while, seems like), which means they're evaluating their last round of participants. Data on the 400-participant trial should be out in the next 3 - 6 months, which will be far more useful for evaluation than the 20-participant Phase I trial. Just hang tight for the real data before jumping to any conclusions about its efficacy.

 

[InNeedOfHelp]

Just FYI, the recruitment for the Phase II trial is now closed (and has been for a while, seems like), which means they're evaluating their last round of participants. Data on the 400-participant trial should be out in the next 3 - 6 months, which will be far more useful for evaluation than the 20-participant Phase I trial. Just hang tight for the real data before jumping to any conclusions about its efficacy.

Final Study completion date moved forward from June to April.

Estimated Primary Completion Date: April 2022
Estimated Study Completion Date: April 2022