New University of Michigan Tinnitus Discovery — Signal Timing

[Chaz]

If this works it should definitely help me. My Tinnitus is noise induced, and I can modulate it by jaw movement, touching my face and tensing my neck.

 

[jer]

@threefirefour i think you are wrong. We used to be the Haiti of the medical community, but this has changed in the last five years if you look st the amount of research papers / trials stared / trials completed. The thing is, this is a multifaceted problem which is not easy to figure out. I have great hope in things coming up (we already had something work.... alas with too many side effects in trobalt).

So now it just requires work on slowly eliminating things that do not work until they find to get to the one that does.

 

[linearb]

Well, the next phase of the trial is going to be again run exclusively out of the Univeristy of Michigan -- and I believe the length of an individual person's experiment will again be something like a month... but they are going to enroll people for 3 years. So, that's "good" from the perspective of getting lots of data, bad from the perspective that the earliest they'd possibly hit market is probably 2022 or something.

I may move forward on trying to cobble together my own thing; the tech here is actually pretty simple, the difficult part is not building the device, but testing that the timing is precisely correct.

If anyone here has a background in electrical engineering or signals analysis, hit me up.

 

[stophiss]

will only add and say thank you linearb for your contribution to this thread. You write with great lucidity and fingers crossed signal timing manifests improvement for a subset of tinnitus sufferers.

 

[Paulmanlike]

Well, the next phase of the trial is going to be again run exclusively out of the Univeristy of Michigan -- and I believe the length of an individual person's experiment will again be something like a month... but they are going to enroll people for 3 years. So, that's "good" from the perspective of getting lots of data, bad from the perspective that the earliest they'd possibly hit market is probably 2022 or something.

I may move forward on trying to cobble together my own thing; the tech here is actually pretty simple, the difficult part is not building the device, but testing that the timing is precisely correct.

If anyone here has a background in electrical engineering or signals analysis, hit me up.

Have you got a link for this information?

Enrolment for 3 years is good, they can draw information from which people would likely to respond; before shelling out money in hope it might work for you.

Look at previous products; the tinnitool for example came with a study of about 70 people and they tried to sell it on the basis of that study alone and it turned out useless.

 

[Markku]

but they are going to enroll people for 3 years.

Are you sure? The information I have from Susan Shore (from around a week ago) is that the trial is going to last about one year.

 

[EatMoTacos]

Well, the next phase of the trial is going to be again run exclusively out of the Univeristy of Michigan -- and I believe the length of an individual person's experiment will again be something like a month... but they are going to enroll people for 3 years. So, that's "good" from the perspective of getting lots of data, bad from the perspective that the earliest they'd possibly hit market is probably 2022 or something.

I may move forward on trying to cobble together my own thing; the tech here is actually pretty simple, the difficult part is not building the device, but testing that the timing is precisely correct.

If anyone here has a background in electrical engineering or signals analysis, hit me up.

I am an Electrical Engineer.

 

[Alue]

I really want to try this. It's interesting, my tinnitus does not change much with jaw movements, however if I press on my zygomatic process right in front of my ear my tinnitus gets much louder (at least the ear portion of my tinnitus). It's like I can feel it in my head, and it always feels like a pissed off nerve.

Does this happen to anyone else?

For those that don't know it's this bone:

 

[DebInAustralia]

Hhhmmmm. I wonder if my tinnitus is modified through these indirect somatic components if I have any? I certainly can't manipulate it with basic movements or poking myself, although when I yawn it appears louder - is that a somatic component?

I think if you yawn, you are able to make your tinnitus louder, I would say you have a somatic element to your tinnitus. Hence, a possible candidate for treatment using this device down the track if/when it hits the market.

 

[DebInAustralia]

Are you sure? The information I have from Susan Shore (from around a week ago) is that the trial is going to last about one year.

You mean the info I emailed you Markku?

 

[Markku]

You mean the info I emailed you Markku?

No, your inquiry had been after mine.

 

[DebInAustralia]

Wrote to Dr. Shore today.

Stated that it is *probable* that the device will be commercialised in 2019.

 

[stophiss]

My tinnitus seems to be at least partly related to neck position due to sleeping, reposing while watching TV etc...and there can be a change in pitch and/or volume when yawning or opening my jaw widely.

Not that I am expected to understand why signal timing would be related to what I presume is nerve impingement on some level, but can someone explain why signal timing is related to what seems to be pressure on certain hearing related nerves that introduces tinnitus?...why signal timing is applicable to this particular 'type' of tinnitus?

Thanks

 

[Fabrikat]

Why signal timing is applicable to this particular 'type' of tinnitus?

Even more basically, I'd like to know what signal timing is. Is it a sound or a current and how is it enacted on the body with Susan Shore's device?

 

[Greg Sacramento]

Susan Shore As I understand, the treatment needs to be customized and delivered on a regular basis. Wondering (regular basis) as in how often. Then after trials and approval process from the FDA's (within the States) from the Center for Devices and Radiological Health ( CDRH), how long will it take for adoption per care specialists. They will have to go thru training and be certified.

If approved and marketed, will this be another treatment where one will have to travel long distances for treatment.

I'm familiar with approval processes from different agencies world wide - and I know that the USA is the slowest. I have a lot more to question, but I've been open minded for now.

 

[NatureHiker]

Susan Shore As I understand, the treatment needs to be customized and delivered on a regular basis. Wondering (regular basis) as in how often. Then after trials and approval process from the FDA's (within the States) from the Center for Devices and Radiological Health ( CDRH), how long will it take for adoption per care specialists. They will have to go thru training and be certified.

If approved and marketed, will this be another treatment where one will have to travel long distances for treatment.

I'm familiar with approval processes from different agencies world wide - and I know that the USA is the slowest. I have a lot more to question, but I've been open minded for now.

IIRC Dr. Shore doesn't need to go through the FDA process to get this treatment to market because it's not a drug. If she wanted to she could sell it tommorow. She's just trying to prove legitimacy and efficacy with a larger study. Possibly also gives her more time to tweak some stuff.

 

[Greg Sacramento]

@NatureHiker So your saying that a premarketing submission 510 (k) isn't needed to demonstrate that the device is safe and effective. I'm not referring to a FDA clinical trial, but certain devices need guidance from the CDRH. This device may not need more than that, but if there was credibility within the stated use, I would think for insurance liability A Class III would be desired.

A PMA isn't needed, but the FDA modernization Act (FDAMA) has a novo classification option which is Evaluation of Automatic Class III designation. This option provides an alternate pathway for devices of low to moderate risk.

I have never seen funding given to a State institution where a University didn't seek a Class III designation for a device. This would refer to MIT, CIT, Cal Poly and many other Universities. I would think that U of M would require this. Then there's consideration of what health professionals and hospitals would use this device if it didn't have a Class III designation.

 

[GregCA]

Dr. Shore doesn't need to go through the FDA process to get this treatment to market because it's not a drug.

You do need FDA approval for medical devices too. It's not limited to drugs.

 

[HomeoHebbian]

Even more basically, I'd like to know what signal timing is. Is it a sound or a current and how is it enacted on the body with Susan Shore's device?

The idea is to deliver a tactile stimulus to the jaw at a specific time interval relative to moderate sound stimulation. Their hypothesis is that this will tap into a process called spike timing-dependent plasticity to dampen a hyperactive neural circuit in the auditory brainstem. The biggest drawback is that the effects will likely be short-lived.

 

[Fabrikat]

The idea is to deliver a tactile stimulus to the jaw at a specific time interval relative to moderate sound stimulation.

Thanks for your explanation @HomeoHebbian! Do you know how they determine the timing of the stimulus? Or is it the same for everybody? I'm assuming it's some kind of mild electrical stimulation.

 

[HomeoHebbian]

Thanks for your explanation @HomeoHebbian! Do you know how they determine the timing of the stimulus? Or is it the same for everybody? I'm assuming it's some kind of mild electrical stimulation.

If I post that information I will put their placebo control at risk, potentially excluding people on this forum from participating in their trial. The timing info is public domain knowledge, if you know where to look. Sorry to be cryptic, but it might be for the best if I don't say.

 

[Fabrikat]

If I post that information I will put their placebo control at risk, potentially excluding people on this forum from participating in their trial. The timing info is public domain knowledge, if you know where to look. Sorry to be cryptic, but it might be for the best if I don't say.

Hmm, I see! I can understand that. I might have to set some kind of 'honey trap' to extract that kind of information from an unsuspecting neuroscientist.

 

[linearb]

If I post that information I will put their placebo control at risk, potentially excluding people on this forum from participating in their trial. The timing info is public domain knowledge, if you know where to look. Sorry to be cryptic, but it might be for the best if I don't say.

Hi @HomeoHebbian - you seem to be better educated on the neurology of this than I am, and I really like and respect what you've had to say in this thread, but I'm not sure this is correct. As a participant in the first trial, this is not consistent with what I was told, so I would like to divulge all that. All the information I'm about to post here is either something I was told as a participant in the first trial (which does not exclude me from the next trial), or has been published by the University itself in a publicly available youtube video.

The sounds that the device plays are not very special, I believe it's basically a fat, broadband square wave across the entire hearable spectrum. The timing of the electrical impulses which either precede or succeed the sound (I believe the latter, but do not remember) is what is important; the electrical impulse needs to correlate to the sound at a very specific interval (sub-millisecond accuracy). I don't remember what the "magic number" is, but the exact numbers from the animal model trial are available in that video.

The placebo control is that either the device in placebo mode plays sounds only without electrical stimulation at all, or the device plays sounds and sends electrical stimulation in a random pattern or one which is not timed correctly. In the Phase-I trial, even the researchers in the lab were not sure which it was -- that was part of the double-blind. Note that the electrical impulses used here are very gentle compared to something like a TENS device. During what I believe to have been the real experimental protocol phase, when I seemed to respond to the device, I was never really aware of the impulses except one time when perhaps I placed the electrode slightly incorrectly and it caused my eye to twitch a little.

I've had some contact with one of the clinicians there about the status of the upcoming study; I will be back to share that here once I get a confirmation from them that everything I have been told is public information.

 

[linearb]

The person I've been in contact with at the University has told me that this information is fine to share here, so here it is. @DebInAustralia it turns out there actually isn't a conflict between what I was told and what Dr. Shore told you:

To clarify the study design: it is a 4 year study, combined animal and humans. The first year is animals only. Recruitment of humans begins in Year 2 and will continue to Year 4.

I spoke with [Dr. Shore] yesterday to get some clarification on when the device might be available. They are still working out a plan and nothing is confirmed yet. However, yes, there is a possibility that the device would be commercially available within a couple years (sooner than the study ends). However, they don't know for sure yet.

 

[Greg Sacramento]

I do think that Susan Shore is conducting practical research. Those with tinnitus who can modify sound levels display muscle tension not anxiety. Somatic intervention - toughened muscles, a signal sent to the trigeminal nerve which also often leads to masticatory hyperactivity.

 

[HomeoHebbian]

Hi @HomeoHebbian - you seem to be better educated on the neurology of this than I am, and I really like and respect what you've had to say in this thread, but I'm not sure this is correct. As a participant in the first trial, this is not consistent with what I was told, so I would like to divulge all that. All the information I'm about to post here is either something I was told as a participant in the first trial (which does not exclude me from the next trial), or has been published by the University itself in a publicly available youtube video.

I've had some contact with one of the clinicians there about the status of the upcoming study; I will be back to share that here once I get a confirmation from them that everything I have been told is public information.

Hi @linearb, we are totally on the same page. What makes the treatment condition special (i.e., different than the control group) is the specific timing between the sound and the tactile stimulation. To adapt the famous George Costanza quote, "it's not a placebo control unless you believe it". The more we talk about their study design, the more we jeopardize the placebo effect for people that my want to participate. In turn, this jeopardizes any conclusions they can make about their trial. I have been the Principal Investigator on a few clinical trials so I am sensitive to this issue. Their study already isn't double-blind, as you yourself said that one control group would have sound alone without tactile stimulation. Obviously, as the subject, it would be pretty easy to tell if you were in the control group, in that case! If we talk about the specific time interval between tactile stimulation and sound stimulation that they think depresses the hyperactive connection then a subject could, in principal, figure out whether they were in the random timing group or the treatment group.

The most frustrating thing about tinnitus research is that the outcome measure (various versions of "how bad is your tinnitus") is entirely subjective, it's purely based on self-report. Any outcome measure of this nature is highly sensitive to placebo effects. If people participating in the trial are randomly sorted into one of their control groups and have reason to doubt that they are in the treatment group, it would very likely bias them to report no change in their tinnitus severity. And then, lo and behold, the investigators will report a difference between their treatment and control conditions when, in fact, the difference could reflect a difference in the belief of efficacy (i.e., the placebo) between groups. We don't want that to happen, do we?

 

[linearb]

Their study already isn't double-blind, as you yourself said that one control group would have sound alone without tactile stimulation. Obviously, as the subject, it would be pretty easy to tell if you were in the control group, in that case!

No, it wouldn't be I was one of the subjects. Phase-I was a crossover design, so I received the real treatment and sham treatment without knowing which is which. There was essentially no difference in how it felt; the voltages being used here are low enough that you're not necessarily able to feel the zaps in a tactile way. I'm suppose I might have worked it out with a voltage meter, but didn't for obvious reasons.

 

[cviechec]

My tinnitus is ototoxicity induced, not noise induced, and tonal in nature. Louder when yawning, I can manipulate my face and change volume SLIGHTLY.

Could oxytocin still help me?

 

[Codaz]

I must agree with Eric, I have emailed Dr.Shore and I was not very impressed.
The research is still in the animal model stage and I didn`t get the impression that it was spectacular. She said IF animal tests will succeed, human trials could begin in at least one year from now.

I e-mailed Dr. Shore a while ago and one of her students replied to me that I need to go to Groningen hospital just to hear that nothing is possible ATM. So I didn't go. I couldn't if I wanted to since you need a referral letter before you are allowed to visit an MD (or his assistant *sigh*) here.

 

[stophiss]

If I post that information I will put their placebo control at risk, potentially excluding people on this forum from participating in their trial. The timing info is public domain knowledge, if you know where to look. Sorry to be cryptic, but it might be for the best if I don't say.

Why would signal timing therapy be short lived? If plasticity morphed aka a bonefide shift in excited neurons creating a new plastic state inducing tinnitus...and this neural track can be damped with competing signal timing, why doesn't it have memory to change permanently?

Thought being, for most of us, tinnitus is a permanent condition...presuming the mechanism that caused tinnitus is related to signal timing being out of sync. Why can't it stay quiet aka permanent morphing of neutralized neurons as it seems there is memory to create tinnitus.
Thanks