New University of Michigan Tinnitus Discovery — Signal Timing

[Aaron123]

So what were the results from the group of patients that were only offered the sound tones?

The author of the article is incorrect. Each of the 20 participants went through both an active treatment and a sham treatment. On average the effect of the sham treatment was statistically insignificant though 4 individuals had clinically significant reductions in TFI during the sham phase (see figure 6 in the paper for the average effects).

 

[EDDTEKK]

Anybody already posted this YouTube film?

 

[vermillion]

Worth noting that Dr. Shore is asked if she thinks tinnitus is curable, and she says it is "probably a preventable problem".

Very stylish evasion. Almost as good as a good politician
Ah... tinnitus, tinnitus...

Personally i am not very enthusiastic about sound-therapy approaches. Regeneration and gene therapies sound more promising, but it's good that there's some fuss in tinnitown. The bad thing with tinnitus is that there's so much heterogeneity among the patients. On the one hand i really hope that this treatment can reduce the volume of many patients and i believe that possibly it will (to some extent). On the other hand i am afraid that it won't work in cases like mine (with no somatosensory symptoms). I really wouldn't like in the above scenario to experience another TRT-like war, where the media will tend to announce with their unique misinforming way that, the tinnitus "cure" have been found, whilst that will not be the case. Don't get me wrong. I remain hopeful and DEFENITELY i would try this treatment. If this lady succeeds in turning the volume down a bit for many people here, it's much better then nothing. Fingers crossed!

 

[Paulmanlike]

I do wonder what Dr Shore's opinion would have been though, even perhaps a more specific question in regards to the word "cure". But yes, she well and truly swerved that question.

 

[erik]

If you are local and near U of M, you can apply to take part in their new clinical trial for 2018. You have to be close to be able to go there once a week during the trial. Email: tinn.trial@umich.edu. (currently this email addy is not working, they are aware of it and will fix it soon)

The email is working now.

 

[SomaticT]

This is promising, but it is important to keep in mind what is actually in the paper.

First, the average reductions in TFI in the active treatment and active washout phases are 7.51 and 6.71 points, respectively. These were both significantly different from 0, but they are both much less than 13 which is the cutoff for clinical significance. Additionally, the mean reduction during the sham phase is about 2 points, and the sham washout has a mean reduction of a bit less than 2. Thus, the effect of the treatment itself (active - sham) is about 5.5 to 4.7 points - not large. Either way, on average the treatment has a statistically significant but clinically insignificant effect on the TFI.

Second, 10 of the 20 subjects did have a clinically meaningful reduction of at least 13 points during the active treatment. This is good. However, we don't know what reductions these individuals had during the sham phase. In fact, 4 participants had clinically significant reductions during the sham phase, and 2 participants had clinically significant reductions during BOTH phases. The authors do say that the two who experienced reductions during both phases experienced larger reductions during the active phase, but they don't provide the information so that the reader can understand the differences. It would have been useful to see individual level data. This would be possible with only 20 subjects, and it would allow the reader to see the degree to which individuals who saw improvement in the active phase also saw improvement in the sham phase. (Ideally you would like to see responses during the active phase and no response during the sham phase for each person. Assuming they are correct that the sham is truly a sham, it acts like a placebo so if you see a reduction in TFI or loudness during the sham period this is due to the placebo effect. That's why you need to subtract out the effect of the placebo in order to determine the effect of the treatment.)

Third, assuming the treatment truly does have a clinically significant reduction for a significant proportion of people who are treated, it would be useful to know ahead of time who might benefit. In this case, there were no demographic differences between the people who improved significantly and those that didn't. This may be due to the very small sample. Assuming the results persist in a larger sample, perhaps observable differences will observe.

Fourth, there is a reduction in loudness during the treatment of about 8 dB. Unlike the reduction in TFI, this effect becomes smaller during the active washout. Thus, it appears that any sustained reduction in perceived loudness requires continued use of the device. However, the 8 dB reduction isn't all due to the treatment. The effect during sham treatment is a reduction in loudness of about 3.5 dB or so (hard to say exactly from the figure). Thus the net reduction due to the treatment is about 4.5 dB. (In Figure 6C, it's interesting that there is a similar relationship from sham to sham washout that there is between the active and active washout.)

Fifth, 2 people did report the elimination of tinnitus "toward the end of the active treatment period" though there is no information the durability of that result.

So there are promising results here, but they aren't earth-shattering. It's important to remember this is a small study with some promising results. We won't really know more until they do a larger study which is or will soon be underway.

After waiting since 1994 for some hope that something could halt the progression of this horrible screeching in my left ear (modulated by pushing on various points on my head, face and neck, most especially pushing down at C1), "promising" is earth-shattering! I'll take any noticeable decrease in ringing and happily and joyfully apply the device 30 mins/day. Heck, I'll do 3 hrs/day or just wear the damn thing everyday all day if they make it portable. And I'll keep wearing it as long as I get a benefit. My god, a non-intrusive non-narcotic therapy!! This is the best news I've heard in 23 years. Let's hope they get the device on the market SOON. Hallelujah! Sign me up! Hope it's sold on amazon soon!!!

 

[SomaticT]

It's not what I want to say, but it's the reality. I have not read the full whitepaper so I don't know how that's discussed, but "temporary relief" was how they set expectations and is expected based on their model of how this is supposed to work. They also told me verbally that the people that it had worked for, had all said the effect wore off within 1-4 weeks.



Wouldn't work; these things are highly proprietary devices; they may well have a kill-switch baked in, and even if they don't, there's no way to make any adjustments, get copies of the software used to manage and monitor them, etc. These are the experimental beta devices; they are in no way designed to survive long-term use. Also you'd be committing felony theft directly harming an institution that's spent the last several years trying to help us. Not cool.

Patience. If it works as well as they think it might, this could hit market significantly faster than a drug would.

I think AZeurotuner raises an excellent point - how can you tell a patient who is being helped by this device that they have to give it back because the trial is over? Harsh. I hope they get this approved and on sale ASAP!!!! Is there a gofundme page for this research???

 

[linearb]

I think AZeurotuner raises an excellent point - how can you tell a patient who is being helped by this device that they have to give it back because the trial is over? Harsh. I hope they get this approved and on sale ASAP!!!! Is there a gofundme page for this research???

the how was saying "I am really sorry, but there are a limited number of these and we need them to continue the study, and we also are not clear on if FDA compassionate use guidelines would be applicable here even if we had extra devices, which we don't."

They were very up front about this at the beginning of the study, when I made it clear that I was willing to incur significant travel costs to be part of the study. It wasn't a bait and switch.

So yeah, it's a bummer; on the other hand, if it works as well as it seems to, they'll know more before they hit market and maybe have something 3-5 years down the line that works even better. If I was really impatient I would just tinker around with building my own device, because I understand the challenges there and it doesn't seem scary. But, for the moment I have too many projects as is, so I'm happy to just let them keep moving forward and see where it all goes.

There must be a lot of people out there who have conditions even more disabling than tinnitus who have been temporarily helped by drugs or other experimental interventions, and then had to go back to just dealing with it after the trial was over. It's all a drag, but that's just how it works, and the alternatives seem worse to me. Making it easier for untested or potentially dangerous treatments to become widely available is hazardous; drug companies especially have a pretty clear disdain for their end-users and a strong interest in making money consequences be damned.

 

[IvanRus]

The researchers also only used volunteers with a particular form of tinnitus. These sufferers are able to soften their episodes by applying pressure to their head or clenching their jaw—a rudimentary version of keeping their fusiform cells in check, it's thought. That could mean the device won't work for the 20 percent to 40 percent of tinnitus sufferers without that particular quirk.

This, of course, upsets.

Did someone contact them? Why only this kind of tinnitus is rudimentary? Patients with other forms of tinnitus they did not even try to use in the study?

It seems to me that the majority here is not a rudimentary form. Also what, for this tinnitus other sites answer, and it is necessary to develop other device? Unclear.

 

[Paulmanlike]

I also have a burning question.

The only way I can change my frequency or volume of tinnitus is if it I put pressure on my ear and then the volume intensifies and frequency goes a little higher, is this somatic tinnitus?

No way of changing it through jaw or neck movements, is there a particular type of cause that will give you 'somatic' tinnitus?

Also, I'm I right in assuming that not all somatic tinnitus can be modulated through neck and head movements/jaw movements but it can be modified temporarily in a way we are not even aware of? Know what I mean? Like we have somatic tinnitus and we don't even know that we do?

 

[Stakovic]

Why they didn't use EEG (otherwise known as an electroencephalogram) To compare the T severity befor and after the treatement.

 

[EDDTEKK]

Does the device work for patients who can soften their Tinnitus by special movements or touches only or also for those where by movement the Tinnitus increases in volume?
This isn't clear for me..

 

[Zug]

the how was saying "I am really sorry, but there are a limited number of these and we need them to continue the study, and we also are not clear on if FDA compassionate use guidelines would be applicable here even if we had extra devices, which we don't."

They were very up front about this at the beginning of the study, when I made it clear that I was willing to incur significant travel costs to be part of the study. It wasn't a bait and switch.

So yeah, it's a bummer; on the other hand, if it works as well as it seems to, they'll know more before they hit market and maybe have something 3-5 years down the line that works even better. If I was really impatient I would just tinker around with building my own device, because I understand the challenges there and it doesn't seem scary. But, for the moment I have too many projects as is, so I'm happy to just let them keep moving forward and see where it all goes.

There must be a lot of people out there who have conditions even more disabling than tinnitus who have been temporarily helped by drugs or other experimental interventions, and then had to go back to just dealing with it after the trial was over. It's all a drag, but that's just how it works, and the alternatives seem worse to me. Making it easier for untested or potentially dangerous treatments to become widely available is hazardous; drug companies especially have a pretty clear disdain for their end-users and a strong interest in making money consequences be damned.

Congratulations on taking the time and volunteering. Imagine in a few years, if this thing works out, you helped the researchers to bring this treatment into the world.

I imagine it is frustrating not to have access to the equipment anymore, but for the best or worse, this is how science works.

Best,
Zug

 

[EDDTEKK]

Didn't see that anybody posted this film from 2010 where she explains some basics of their findings and ideas.

 

[IvanRus]

I understand that they work only with rudimentary tinnitus. And rudimentary tinnitus is tinnitus not associated with damage to the inner ear? Is it vascular and other tinnitus? Then, I think most of us will not use this device. Why it is impossible to do a similar study of the "non-conventional" classical tinnitus, and make an apparatus for this species. Is it harder ?! I have no pressure on the temporal bones, etc., do not affect the tinnitus .. And I first hear about this division (classification) of tinnitus.

 

[linearb]

I understand that they work only with rudimentary tinnitus. And rudimentary tinnitus is tinnitus not associated with damage to the inner ear?

where did you get that idea? That's not correct; this work is entirely based on hearing damage as a tinnitus cause. In the animal models they induced unilateral tinnitus by blasting animal's ears with broadband noise. (Of course this doesn't cause tinnitus in all the animals, but there are convincing behavioral tinnitus correlates in animals which have been developed over the decades leading to this research).

 

[Thomt]

This is 6 years old now. Is there anything new about it?

 

[WaqasVic]

This is 6 years old now. Is there anything new about it?

The idea is 6 years old, they have developed the device now and testing it. Hope to see it in the market soon.

From all of the tinnitus research news this is the only news that made it to the mainstream media, this is pretty hopeful.

 

[Tom Soria]

Did they mention whether this would help people who have pulsatile tinnitus and hyperacusis?

 

[Paulmanlike]

Did they mention whether this would help people who have pulsatile tinnitus and hyperacusis?

It's not designed for pulsatile tinnitus or hypercausis sorry. you could always email and ask them but I think you would get a similar answer. Hope I'm wrong though and it benefits you.

 

[Joe Bananas]

Perhaps this has been questioned before but what if someone using the device in a daily basis is exposed to a new acoustic trauma which increases the volume of T? I mean, maybe this therapy leads to certain peace of mind in which one is not as cautious anymore and doesn't protect him/herself from noises in the way someone with constant T does.
Also here in Spain there is a big hearing aids seller which has a TRT protocol and sells all its stuff at ridiculously abusive high prices. I can perfectly see them either way selling the device at a prohibitive price tag or having the device themselves in their consults to make the patients go there to receive the therapy again at a grotesque cost.

 

[IvanRus]

The author of the article is incorrect. Each of the 20 participants went through both an active treatment and a sham treatment. On average the effect of the sham treatment was statistically insignificant though 4 individuals had clinically significant reductions in TFI during the sham phase (see figure 6 in the paper for the average effects).

What amazes me is that it does not work for all people with tinnitus .. What does this have to do with? Are there different mechanisms that require different approaches, even if the only reason is hearing loss? Do everyone here have a so-called "rudimentary" tinnitus, in which, squeezing the jaw gives an increase in tinnitus? My hypothesis is one - rudimentary tinnitus in those with an organ affected by corti. Neradventural (tinnitus does not change when pressing on the forehead, jaw clenching) - are those who have damaged the 8th cranial (auditory) nerve? This is true?

 

[hans799]

Do everyone here have a so-called "rudimentary" tinnitus, in which, squeezing the jaw gives an increase in tinnitus?

1. The proper name for this is "somatic" tinnitus, not "rudimentary"

2. According to research, 60-80% of all tinnitus sufferers have this somatic subtype. So most, but definitely not all people.

 

[IvanRus]

1. The proper name for this is "somatic" tinnitus, not "rudimentary"

2. According to research, 60-80% of all tinnitus sufferers have this somatic subtype. So most, but definitely not all people.

That is, somatic tinnitus have everything from whom it is associated with this or that hearing loss (the same 60-80%). The remaining 20-40% is psychosomatic, vascular noise and so on?

 

[Aaron44126]

I registered for the trial and received a note stating that it is expected to begin in "early fall". Since it is university-driven I suppose they will be executing it during the fall semester (September/October/November).

Still hoping that my tinnitus resolves itself naturally by then but if not, and if I actually get into the trial, it will certainly be an interesting experience I think!

 

[Joeymeatballs]

Does the device work for patients who can soften their Tinnitus by special movements or touches only or also for those where by movement the Tinnitus increases in volume?
This isn't clear for me..

I was also having trouble figuring this out, but after reading a peer reviewed paper last night on somatic tinnitus im 95% sure that increase in loudness is also somatic. I know one of the news articles I read said somatic only lowers it, but I am almost positive that was a mistake by the journalist.

 

[tinniwalker]

In this video -

starting at 26:00 Susan Shore talks about the modulation of tinnitus with clenching the jaw and gives an example of a person who is able change the pitch (not volume) of his tinnitus with moving the jaw forward and back. So, the ability of modulation (changing the tone and/or volume) of the tinnitus is important, not the softening of it.

 

[valeri]

Does this means that it won't be helpful to those with "brain" tinnitus that can't be influenced by body movements?

Is tinnitus considered somatic if it temporarily reduces when doing that finger tapping technique on the back of the head?

 

[SomaticT]

The idea is 6 years old, they have developed the device now and testing it. Hope to see it in the market soon.

From all of the tinnitus research news this is the only news that made it to the mainstream media, this is pretty hopeful.

This is taking a looong time. It's just a silly device that emits a tone and delivers an electric shock. This is what happens when academics don't partner with a commercial entity. Dr Shore needs investors and a commercial partner! Start your little company and license your IP to somebody that can run with this!

The first clinical trial started recruiting years ago and only had 20 subjects over 16 weeks. Please get a commercial partner that knows how to do this! Not just you and a bioengineering grad student. Talk about great idea and small potatoes? Why isn't anybody interested in developing this with 50 million potential customers???

Sorry to ramble, folks, but it's frustrating to watch while an academic struggles to get a potential therapeutic device to patients that are suffering. Get the ego out of the way, find a CEO that has a track record of success, and stop trying to do everything, you'll make plenty of money if you hurry.

 

[Localboy]

you'll make plenty of money if you hurry.

They will make plenty of money even if they don't hurry...