New University of Michigan Tinnitus Discovery — Signal Timing

[DoNotGoGentle]

@DoNotGoGentle, did you end up speaking to Susan Shore's office in May? Have they published any new trial outcomes as far as you're aware and is she still planning on further trials this year? They've been very quiet over there of late.

Yeah I spoke with her asked her about the trial she said still waiting for funding. Call back in a couple of months. Not much more to add sorry

 

[Fabrikat]

Yeah I spoke with her asked her about the trial she said still waiting for funding.

Thanks for replying @DoNotGoGentle. You'd think if the device had already demonstrated efficacy, there'd be a pile of cash waiting to take it to the next level. Interesting!

 

[NatureHiker]

Yeah I spoke with her asked her about the trial she said still waiting for funding. Call back in a couple of months. Not much more to add sorry

Sad to hear that. I normally donate to Mass Ear and Eye, but maybe I'll shift it to Kresge. Not like it'll make any difference though.

I was really looking forward to this treatment advancing. Sucks it's stalled.

 

[DoNotGoGentle]

Sad to hear that. I normally donate to Mass Ear and Eye, but maybe I'll shift it to Kresge. Not like it'll make any difference though.

I was really looking forward to this treatment advancing. Sucks it's stalled.

The problem is it is government funded if it was private then it go much faster! They want to start phase II. We shall see!!!

 

[NatureHiker]

The problem is it is government funded if it was private then it go much faster! They want to start phase II. We shall see!!!

Crossing my fingers NIH funds the next phase.

Additionally what phase are they on??? The clinicaltrials.gov page doesn't say https://clinicaltrials.gov/ct2/show/NCT02974543 and I thought they didn't test efficacy in phase 1. Just safety. Unless they're doing the phase 1/2 then phase 2/3 kind of thing I've seen before.

 

[Aaron123]

The problem is it is government funded if it was private then it go much faster! They want to start phase II. We shall see!!!

Crossing my fingers NIH funds the next phase.

Additionally what phase are they on??? The clinicaltrials.gov page doesn't say https://clinicaltrials.gov/ct2/show/NCT02974543 and I thought they didn't test efficacy in phase 1. Just safety. Unless they're doing the phase 1/2 then phase 2/3 kind of thing I've seen before.

This isn't a drug trial so there aren't three phases. She presumably wants to do a larger study and/or to tweak the approach in some way.

Two things are worth noting:

1) According to the clinicaltrials.gov entry, the average reduction in TFI for the treatment when treatment was given before sham was 10 points. When treatment was given after sham, the reduction was only 5.3 points. Both of these are smaller than the usual definition of a clinically meaningful change in the TFI of 13 points (https://www.audiology.org/sites/default/files/publications/tinnitusFunctionalIndex.pdf). Of course it is hard to learn much from 20 people.

2) Dr Shore and two colleagues have a patent on this approach: http://www.freepatentsonline.com/9682232.html

 

[NatureHiker]

This isn't a drug trial so there aren't three phases. She presumably wants to do a larger study and/or to tweak the approach in some way.

Two things are worth noting:

1) According to the clinicaltrials.gov entry, the average reduction in TFI for the treatment when treatment was given before sham was 10 points. When treatment was given after sham, the reduction was only 5.3 points. Both of these are smaller than the usual definition of a clinically meaningful change in the TFI of 13 points (https://www.audiology.org/sites/default/files/publications/tinnitusFunctionalIndex.pdf). Of course it is hard to learn much from 20 people.

2) Dr Shore and two colleagues have a patent on this approach: http://www.freepatentsonline.com/9682232.html

Thanks! I guess a larger study and improvements would be great to further solidify this treatment. I've heard great things about it which is why i can't wait.

Frustrating to see that the it's not clinically significant. I heard other researchers are flustered because their treatments don't show much clinical significance in trials too. I don't get it either. Something should be working by this point. Is everything just ineffective or are the results less promising because its hard to stratify each person by their type of tinnitus and each treatment works best on some types of tinnitus and bad on others?

 

[jer]

Again, as I have said so many times. Once they stop using mice as test animals, who biologically in no way even closely resemble humans, is probably going to be when we have less baffled researchers that they methods are not working.

We need to be testing drugs on animals that actually resemble humans to get sound results!

 

[DoNotGoGentle]

Again, as I have said so many times. Once they stop using mice as test animals, who biologically in no way even closely resemble humans, is probably going to be when we have less baffled researchers that they methods are not working.

We need to be testing drugs on animals that actually resemble humans to get sound results!

Correct but it is proof of concept! I agree once we have proof it works then stop with the animals maybe use on people on death row!

 

[threefirefour]

When does Susan Shore's signal timing end their second trials? I hear it's in fall 2017.

People who have been in the first ones like @DebInAustralia, do you think there's potential? I hear funding is an issue but I can't find anything on it.

 

[Markku]

September 2017 Update on the trial

Dr. Shore stated the following:

"We have secured funding and will begin the trial next year."

 

[Paulmanlike]

September 2017 Update on the trial

Dr. Shore stated the following:

"We have secured funding and will begin the trial next year."

Link? Or did she contact you direct? Thanks.

 

[Alberte]

Markku, can you give me the address of the website of the research of Dr. Shore. Thank you!

 

[Markku]

Link? Or did she contact you direct? Thanks.

No link. Direct contact.

Markku, can you give me the address of the website of the research of Dr. Shore. Thank you!

Here's a thorough selection of links:

• https://medicine.umich.edu/dept/khri/faculty-labs/labs/shore-laboratory
• https://experts.umich.edu/en/persons/susan-e-shore
• https://medicine.umich.edu/dept/khri/susan-e-shore-phd

 

[threefirefour]

September 2017 Update on the trial

Dr. Shore stated the following:

"We have secured funding and will begin the trial next year."

Markku, thank you for reaching out to Susan Shore for me. Personally I fully believe that Susan shore's signal timing is the way to go in reducing or eliminating tinnitus, and I'm glad she will be participating in human trials next year, which I assume will go over well after the modifications made after the last trial. I'm still sad that they won't be beginning this month like I thought they would.

 

[Paulmanlike]

How's this different to other VNS methods such as MuteButton, and the stuff out of Helsinki Ear Institute?

 

[Paulmanlike]

Isn't Susan Shore's device only aimed to help those with somatic tinnitus? (tinnitus that can be changed by moving the neck, pressing the face)?

 

[linearb]

How's this different to other VNS methods such as MuteButton, and the stuff out of Helsinki Ear Institute?

This device is a "reductionist" or ground-up model: they started by doing research that led them to identify one very specific mechanism that seems to relate to tinnitus, then devised a technology aimed at targeting that mechanism in a very specific way. On the other hand, AFAIK VNS has been a "holistic" or top-down approach: they started with the observation that some people who get VNS for other reasons reported a reduction in their tinnitus.

There are advantages and disadvantages to either approach.

Isn't Susan Shore's device only aimed to help those with somatic tinnitus? (tinnitus that can be changed by moving the neck, pressing the face)?

Yes, and probably only a subset of even those people. However, 80% of tinnitus patients have some degree of somatic involvement. If Dr. Shore's model of noise-induced tinnitus is remotely accurate, it basically means that essentially all noise-induced tinnitus has a somatic component (though in some people the sensory component could relate to nerves which are not directly accessible through basic movements or poking yourselves).

Having basically decent hearing as well as a somatic component that can be manipulated through muscle movement is necessary for using this device, because the theory is that the device works by stimulating the same muscles that are connected to the tinnitus hyperactivity along with the auditory nerve with noise, in a way which is very precisely timed and causes a homeostatic mechanism called "spike-timing dependent plasticity" to reorganize information pathways in the dorsal cochlear nucleus in a way that reduces the tinnitus hyperactivity.

 

[Paulmanlike]

This device is a "reductionist" or ground-up model: they started by doing research that led them to identify one very specific mechanism that seems to relate to tinnitus, then devised a technology aimed at targeting that mechanism in a very specific way. On the other hand, AFAIK VNS has been a "holistic" or top-down approach: they started with the observation that some people who get VNS for other reasons reported a reduction in their tinnitus.

There are advantages and disadvantages to either approach.

Yes, and probably only a subset of even those people. However, 80% of tinnitus patients have some degree of somatic involvement. If Dr. Shore's model of noise-induced tinnitus is remotely accurate, it basically means that essentially all noise-induced tinnitus has a somatic component (though in some people the sensory component could relate to nerves which are not directly accessible through basic movements or poking yourselves).

Having basically decent hearing as well as a somatic component that can be manipulated through muscle movement is necessary for using this device, because the theory is that the device works by stimulating the same muscles that are connected to the tinnitus hyperactivity along with the auditory nerve with noise, in a way which is very precisely timed and causes a homeostatic mechanism called "spike-timing dependent plasticity" to reorganize information pathways in the dorsal cochlear nucleus in a way that reduces the tinnitus hyperactivity.

Did you try it in clinical trials? What was your experience? Did it reduce it and if so by how much?

Does this mean for those sufferers who can't manipulate their tinnitus with face and neck movements etc won't benefit from this device? Thanks

 

[Paulmanlike]

Has anybody got a link to the study performed on the 20 subjects by this method? Here is a link to the recruitment of it

https://clinicaltrials.gov/ct2/show/results/NCT02974543?sect=X40156#othr

 

[BuzzyBee]

Having basically decent hearing as well as a somatic component that can be manipulated through muscle movement is necessary for using this device, because the theory is that the device works by stimulating the same muscles that are connected to the tinnitus hyperactivity along with the auditory nerve with noise, in a way which is very precisely timed and causes a homeostatic mechanism called "spike-timing dependent plasticity" to reorganize information pathways in the dorsal cochlear nucleus in a way that reduces the tinnitus hyperactivity.

Does it matter what ear has the "decent hearing"? For instance, if the tinnitus is mostly in the left ear and the left ear is deaf, can the device work if the right ear is fine?

 

[linearb]

Did you try it in clinical trials? What was your experience? Did it reduce it and if so by how much?

It's hard to provide a "how much" for such subjective experiences. My feeling was that it worked to some significant extent but definitely was not a cure.

Does this mean for those sufferers who can't manipulate their tinnitus with face and neck movements etc won't benefit from this device? Thanks

Yes.

Does it matter what ear has the "decent hearing"? For instance, if the tinnitus is mostly in the left ear and the left ear is deaf, can the device work if the right ear is fine?

Unknown based on the current data, though in phase-I they tested unilaterally and some people did report bilateral effects, so it's possible that treating the right ear could help the left. People with bilateral deafness will not be treatable in this way.

 

[Paulmanlike]

However, 80% of tinnitus patients have some degree of somatic involvement. If Dr. Shore's model of noise-induced tinnitus is remotely accurate, it basically means that essentially all noise-induced tinnitus has a somatic component (though in some people the sensory component could relate to nerves which are not directly accessible through basic movements or poking yourselves).

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?

 

[threefirefour]

It's hard to provide a "how much" for such subjective experiences. My feeling was that it worked to some significant extent but definitely was not a cure.


Yes.


Unknown based on the current data, though in phase-I they tested unilaterally and some people did report bilateral effects, so it's possible that treating the right ear could help the left. People with bilateral deafness will not be treatable in this way.

In what way did it "significantly" help? Did it lower the volume? If yes then it's a success but if not then it's a failure.

 

[linearb]

In what way did it "significantly" help? Did it lower the volume? If yes then it's a success but if not then it's a failure.

I've written about this extensively in the past, and I'm not interested in arguing about it. Unlike nearly everyone else with an opinion in this thread, I've used the thing, I thought it worked, and I'm chomping at the bit for them to get something to market.

My subjective ratings for distress and volume plummeted after 2 weeks of using the device, and rebounded back to baseline within a week of the trial being over. I don't have access to the data about the objective volume measurement that they did during the study, so I can't tell you if it "really lowered the volume".

I've also had tinnitus for a long time, and I personally do not need silence/"a total cure"/etc to be happier and more functional. My tinnitus never really seems to change in volume, exactly, it's a question of to what extent it's passive background and to what extent it's piercing/painful/very foreground data. The latter two weeks of the trial, the noise was comfortably doing a quiet thing in the back of my mind, and I suspect that if that was my baseline, I would quickly stop regarding this as any kind of problem. 20 years in, a constant tape hiss does not seem like a problem to me; a piercing/stabbing/physically uncomfortable jab in my ear definitely does. That's the spectrum of my tinnitus, and I can not with certainty say there is a difference in "volume" from one extreme to the other.

If you're in the absolutest camp who demands an absolute return to silence before we can say "success", then you will need to look elsewhere.

I am sorry if I am being combative; I am extremely tired, hundreds of miles from my home my wife and my kid, and pretty much every time I login here I end up getting drawn into something that makes me regret it.

 

[linearb]

although when I yawn it appears louder - is that a somatic component?

IANAD, but, sure sounds like it -- jaw muscles were one of the two common treatment targets they used in phase I.

 

[threefirefour]

I've written about this extensively in the past, and I'm not interested in arguing about it. Unlike nearly everyone else with an opinion in this thread, I've used the thing, I thought it worked, and I'm chomping at the bit for them to get something to market.

My subjective ratings for distress and volume plummeted after 2 weeks of using the device, and rebounded back to baseline within a week of the trial being over. I don't have access to the data about the objective volume measurement that they did during the study, so I can't tell you if it "really lowered the volume".

I've also had tinnitus for a long time, and I personally do not need silence/"a total cure"/etc to be happier and more functional. My tinnitus never really seems to change in volume, exactly, it's a question of to what extent it's passive background and to what extent it's piercing/painful/very foreground data. The latter two weeks of the trial, the noise was comfortably doing a quiet thing in the back of my mind, and I suspect that if that was my baseline, I would quickly stop regarding this as any kind of problem. 20 years in, a constant tape hiss does not seem like a problem to me; a piercing/stabbing/physically uncomfortable jab in my ear definitely does. That's the spectrum of my tinnitus, and I can not with certainty say there is a difference in "volume" from one extreme to the other.

If you're in the absolutest camp who demands an absolute return to silence before we can say "success", then you will need to look elsewhere.

I am sorry if I am being combative; I am extremely tired, hundreds of miles from my home my wife and my kid, and pretty much every time I login here I end up getting drawn into something that makes me regret it.

A definite cure is the endgame but a treatment to reduce noise is definitely a good thing. If it doesn't do that though it's not a success. I do think it will succeed though and be sold in late 2018 or early 2019.

 

[linearb]

A definite cure is the endgame but a treatment to reduce noise is definitely a good thing. If it doesn't do that though it's not a success. I do think it will succeed though and be sold in late 2018 or early 2019.

I'm also optimistic, and might see about participating again in the next round of trials.

 

[Onsdag]

A definite cure is the endgame but a treatment to reduce noise is definitely a good thing. If it doesn't do that though it's not a success. I do think it will succeed though and be sold in late 2018 or early 2019.

We can make our tinnitus less loud in 2019! I'm jumping in joy.

 

[threefirefour]

I'm also optimistic, and might see about participating again in the next round of trials.

I'm certainly not optimistic considering the tinnitus community is basically the Haiti of medical communities, but off of reviews of signal timing I think that it has some serious potential. My main grievance was the fact that's the trial was too short, and had very little time for results to come into fruition. I hope this time around the trial is longer.