New University of Michigan Tinnitus Discovery — Signal Timing

[Nick47]

I finally did get a response from Dr. Shore on treating one ear with her device. This is what she had to say:

Tim,

I apologize for the tardy response, but I have been busy with deadlines.

The unilateral treatment is based on the animal studies with unilateral hearing loss, which can affect both cochlear nuclei. But, since tinnitus is generated in the brain, unilateral treatment appears to alleviate the perception of tinnitus on both sides. There are numerous pathways for influencing the other side.

Best wishes,
Susan

I thought that was very interesting and explains why they only use one earbud in her treatment!

I was digging around and found this:

"Here we demonstrate that unilateral sound exposure causes development of hyperactivity in both the contra and ipsilateral inferior colliculus in mice."

Effect of Unilateral Acoustic Trauma on Neuronal Firing Activity in the Inferior Colliculus of Mice​

 

[AfroSnowman]

Quite. Also, in a trial situation we can't rule out the effect of participants' pre-treatment expectations as a factor when filling out a psychological metric post-treatment.

Personally, as someone who's lived with tinnitus for 30 years, my expectation is such that I'm not looking for silence. A 75% reduction in volume, however, would be out-of-this-world. Quite frankly though, a 15-30% reduction would still make me ecstatic.

This is why we need to see the data for chronicity, and assess how those trial participants who are a few years into this have faired on an invidual basis before I think we can draw some more solid conclusions.

Well the fact that this is a brain focused treatment gives me significant hope that it will work for long haulers. And I mean why not? I know with mine, which I've had for a bit more than 3 years, it remains strongly somatic, pulling my face clearly changes the sound now as much as ever. If the treatment impacts this nerve connection to the tinnitus, hopefully it doesn't matter how long you've had it.

 

[Tomas80]

A few slides that weren't yet shared in the Palm Springs Hearing Seminar thread:

View attachment 52247

View attachment 52248

View attachment 52249

In the bottom graph, did all the purple points above the zero axis mean an increase in tinnitus volume? How do you understand the bottom graph?

 

[Hazel]

In the bottom graph, did all the purple points above the zero axis mean an increase in tinnitus volume? How do you understand the bottom graph?

Yes, that is indeed how I would interpret the graph as well. And the people in the top right quadrant are worst off because both their loudness and TFI increased. The majority of people seem to be in the opposite (lucky) quadrant, but still...

 

[Nick47]

Yes, that is indeed how I would interpret the graph as well. And the people in the top right quadrant are worst off because both their loudness and TFI increased. The majority of people seem to be in the opposite (lucky) quadrant, but still...

Yep, bottom left is where you want to be. Is this after 6 or 12 weeks though?

Looks like 6 weeks as it says 'active treatment'.

 

[TinnyCanMan]

Question: If tinnitus helps prevent cognitive decline, then would silencing tinnitus cause cognitive decline?

 

[JRC1]

At least 30 weeks, but I wonder if impact of the treatment continued to improve with time. There is a downward slope that just stops being measured at 12 weeks, if that trend continues for 16 or 20 weeks the actual final impact of the treatment may be considerably greater.

@AfroSnowman, this is a great point. i appreciate posts which offer hope. For all we know, the slope could continue to zero tinnitus. Thank you.

 

[Kam75]

Question: If tinnitus helps prevent cognitive decline, then would silencing tinnitus cause cognitive decline?

Honestly I was kind of surprised to learn that tinnitus helps prevent cognitive decline!

I mean, when you're so severely affected by tinnitus, to the point of only sleeping 2 or 3 hours a night, how the hell can lack of sleep contribute to preventing cognitive decline?

When you sleep so little, the opposite happens: you function more slowly, you think more slowly, your body does not regenerate...

Well, I don't understand this point. This is mysterious, and personally I can't believe it.

 

[Tomas80]

Yes, that is indeed how I would interpret the graph as well. And the people in the top right quadrant are worst off because both their loudness and TFI increased. The majority of people seem to be in the opposite (lucky) quadrant, but still...

I am totally confused by that graph. There are purple dots in the upper left quadrant, at the very top.

Has someone in the trial had their tinnitus increase by more than 20 dB (1 unit is 6 dB) and at the same time had their TFI decrease by about 13 points (1 unit is 13 points)? Because those points are in the negative part of the TFI graph... I really don't understand it at all

I expected that no one would have an increase in volume. Personally, I can't imagine a worsening even by a 1 dB. I'm on the edge of my life. Are we going to take the risk?

Everyone, please give me your opinions, it really worries me. Thanks.

 

[Aussie Lea]

Has someone in the trial had their tinnitus increase by more than 20 dB (1 unit is 6 dB) and at the same time had their TFI decrease by about 13 points (1 unit is 13 points)? Because those points are in the negative part of the TFI graph... I really don't understand it at all

I expected that no one would have an increase in volume. Personally, I can't imagine a worsening even by a 1 dB. I'm on the edge of my life. Are we going to take the risk?

Everyone, please give me your opinions, it really worries me. Thanks.

That's what it means. Treatments always have outliers who do worse or better than the average.

 

[Bambam0]

View attachment 52249

"The treatment effect was so pronounced that subjects did not return to baseline during the washout period."

Again, hate to get my hopes up but JFC!

 

[Kam75]

I am totally confused by that graph. There are purple dots in the upper left quadrant, at the very top.

Has someone in the trial had their tinnitus increase by more than 20 dB (1 unit is 6 dB) and at the same time had their TFI decrease by about 13 points (1 unit is 13 points)? Because those points are in the negative part of the TFI graph... I really don't understand it at all

I expected that no one would have an increase in volume. Personally, I can't imagine a worsening even by a 1 dB. I'm on the edge of my life. Are we going to take the risk?

Everyone, please give me your opinions, it really worries me. Thanks.

It also starts to worry me, but I'll try my best to stay positive: what if these cases of worsening aren't really due to the device?

I have a personal experience regarding this: I visited a French tinnitus specialist recently who's been taking care of me. One of the things I told him about was my concerns about SSRI antidepressants, as I had read on the Internet (and on Tinnitus Talk in particular) that these types of antidepressants could make pre-existing tinnitus worse. He replied that it is very difficult to categorically blame a drug, because very often we tinnitus sufferers develop a certain fear of drugs and automatically (sometimes without reason) attribute a potential worsening of our tinnitus to the treatment we are taking. According to him there is very little chance that an SSRI antidepressant will make tinnitus worse.

Perhaps a parallel can be drawn with Dr. Shore's device: perhaps it is not the device itself that would have aggravated the tinnitus (I hope so, again to remain positive).

One has to remember that when you take part in this kind of clinical trial, you are absolutely even more focused on your tinnitus, which may have a link.

I think we'll know more when we get the final results.

 

[xyz]

I am totally confused by that graph. There are purple dots in the upper left quadrant, at the very top.

Has someone in the trial had their tinnitus increase by more than 20 dB (1 unit is 6 dB) and at the same time had their TFI decrease by about 13 points (1 unit is 13 points)? Because those points are in the negative part of the TFI graph... I really don't understand it at all

I expected that no one would have an increase in volume. Personally, I can't imagine a worsening even by a 1 dB. I'm on the edge of my life. Are we going to take the risk?

Everyone, please give me your opinions, it really worries me. Thanks.

That's how I understand the upper left quadrant as well. For those the treatment increased loudness, but reduced TFI. I am also wondering how that's possible.

 

[Samwise_The_Loud]

Yes, that is indeed how I would interpret the graph as well. And the people in the top right quadrant are worst off because both their loudness and TFI increased. The majority of people seem to be in the opposite (lucky) quadrant, but still...

Not going to lie, that does worry me. I have not had the best of luck on these types of devices so I'll probably fall into an outlier group.

It seems the left side is the 'better' side to be in. BUT somehow you can have a dB increase, but a TFI decrease? Trying to work that one out.

That graph has somewhat dampened my spirits. Ah well, I suppose it seemed too good to be true.

 

[int999]

People here are very well aware of my view that the average tinnitus patient will experience automatic central nervous system habituation within 2-3 years of onset. Applying treatment within this window of potential regression has always been problematic for me.

Why do you think it's problematic? What's wrong with treating tinnitus before one habituates to it?

 

[Damocles]

Yet, Zeng & Co have used data from the large-scale population study NHANES to prove the opposite. His results show that while hearing loss by itself does cause (quite significant) cognitive decline, this decline in fact is mitigated to some extent by having tinnitus (!).

Honestly I was kind of surprised to learn that tinnitus helps prevent cognitive decline!

Question: If tinnitus helps prevent cognitive decline, then would silencing tinnitus cause cognitive decline?

 

[Samwise_The_Loud]

Question: If tinnitus helps prevent cognitive decline, then would silencing tinnitus cause cognitive decline?

In honesty, I don't think so.

Getting a good night's sleep can work wonders for the mind and I think, with the serotonin boost of having no tinnitus, I couldn't care less if I had cognitive decline...

Sorry, I don't mean to be a downer. Bad tinnitus day. I think the results are promising, but it'll likely be some more years of testing and fine-tuning than we thought. But let's wait to see what Dr. Shore says in full, perhaps if we get her on the Tinnitus Talk Podcast.

 

[AfroSnowman]

It also starts to worry me, but I'll try my best to stay positive: what if these cases of worsening aren't really due to the device?

I have a personal experience regarding this: I visited a French tinnitus specialist recently who's been taking care of me. One of the things I told him about was my concerns about SSRI antidepressants, as I had read on the Internet (and on Tinnitus Talk in particular) that these types of antidepressants could make pre-existing tinnitus worse. He replied that it is very difficult to categorically blame a drug, because very often we tinnitus sufferers develop a certain fear of drugs and automatically (sometimes without reason) attribute a potential worsening of our tinnitus to the treatment we are taking. According to him there is very little chance that an SSRI antidepressant will make tinnitus worse.

Perhaps a parallel can be drawn with Dr. Shore's device: perhaps it is not the device itself that would have aggravated the tinnitus (I hope so, again to remain positive).

One has to remember that when you take part in this kind of clinical trial, you are absolutely even more focused on your tinnitus, which may have a link.

I think we'll know more when we get the final results.

The scatter graph doesn't show change over time, all it shows is the relationship between changes in dB and TFI.

There are a ton of data points on that graph, way more than n=99. I suspect this shows something like the weekly/daily Tinn Tester measurement against TFI. We know tinnitus is super variable, maybe most of those increases were in the first week or two of treatment and best explained by some days being louder than others.

The chart doesn't say anything about improvement or worsening over time.

 

[Travis Henry]

It also starts to worry me, but I'll try my best to stay positive: what if these cases of worsening aren't really due to the device?

I have a personal experience regarding this: I visited a French tinnitus specialist recently who's been taking care of me. One of the things I told him about was my concerns about SSRI antidepressants, as I had read on the Internet (and on Tinnitus Talk in particular) that these types of antidepressants could make pre-existing tinnitus worse. He replied that it is very difficult to categorically blame a drug, because very often we tinnitus sufferers develop a certain fear of drugs and automatically (sometimes without reason) attribute a potential worsening of our tinnitus to the treatment we are taking. According to him there is very little chance that an SSRI antidepressant will make tinnitus worse.

Perhaps a parallel can be drawn with Dr. Shore's device: perhaps it is not the device itself that would have aggravated the tinnitus (I hope so, again to remain positive).

One has to remember that when you take part in this kind of clinical trial, you are absolutely even more focused on your tinnitus, which may have a link.

I think we'll know more when we get the final results.

Don't listen to your doctor. Stay away from taking any drugs as much as you can. Especially benzos or antidepressants. Staying clean is the best option for tinnitus.

I am also wondering if Dr. Shore's device can help people with reactive tinnitus and hyperacusis. Not sure I'll be around to use it, but going to try hard to make it. My sound tolerance is zero and tinnitus is screaming with what feels like 120 dB in my head. I pray I somehow can make it.

 

[Manny]

based on yesterday, there's limited time and not all gets answered

Was it possible to ask that placebo question in the end?

 

[Markku]

Was it possible to ask that placebo question in the end?

@Hazel mentioned this in the notes (taken from the Palm Springs Hearing Seminar thread):

• Control: Participants were not able to distinguish between the sham (control) treatment and the real one, because the electrical stimulation is so soft you cannot feel it.

 

[Tomas80]

The scatter graph doesn't show change over time, all it shows is the relationship between changes in dB and TFI.

There are a ton of data points on that graph, way more than n=99. I suspect this shows something like the weekly/daily Tinn Tester measurement against TFI. We know tinnitus is super variable, maybe most of those increases were in the first week or two of treatment and best explained by some days being louder than others.

The chart doesn't say anything about improvement or worsening over time.

The scatter graph looks like the post-treatment data because there are two types of data, active group and control group. Both groups experienced worsening. Without explanations from Dr. Shore, it looks very disturbing to me. Hopefully everything will be explained soon.

 

[UKBloke]

Why do you think it's problematic? What's wrong with treating tinnitus before one habituates to it?

Looking back at that statement now, the words 'applying treatment' were a slip on my part. What I meant to say was, research measured in part by psychological metrics that focuses on treating people pre-habituation is problematic for me.

 

[Gb3]

So is this good news or not? I'm extremely confused about all the talk on this thread.

 

[Manny]

@Hazel mentioned this in the notes (taken from the Palm Springs Hearing Seminar thread):

• Control: Participants were not able to distinguish between the sham (control) treatment and the real one, because the electrical stimulation is so soft you cannot feel it.

Thank you. I did notice that helpful quote via @Hazel, but I felt it remains odd because it contradicts the ClinicalTrials.gov trial consent form which stated "you may or may not feel the stimulation from the pads".

 

[PeterPan]

There are a ton of data points on that graph, way more than n=99. I suspect this shows something like the weekly/daily Tinn Tester measurement against TFI. We know tinnitus is super variable, maybe most of those increases were in the first week or two of treatment and best explained by some days being louder than others.

Yes, on some days I can hardly hear my tinnitus and on others it is quite bad. So, if I started the treatment on a good day, and then had a reading after the treatment on a bad day, the result could potentially be a lot worse, but maybe not as bad as it would have been without the treatment?

Also, note the green dots. They are not having any treatment but there is a wild variation. This is consistent with the above.

Using an average reading over a couple of weeks before the start of the treatment and at the end would be more meaningful.

The graph is titled "Loudness and TFI descrases correlate during active (bi-sensory) treatment", so yes, this makes sense.

 

[AfroSnowman]

Also, note the green dots. They are not having any treatment but there is a wild variation. This is consistent with the above.

Using an average reading over a couple of weeks before the start of the treatment and at the end would be more meaningful.

The graph is titled "Loudness and TFI descrases correlate during active (bi-sensory) treatment", so yes, this makes sense.

I noted the same thing with the control group. Just a superficial glance at the scatter chart doesn't seem to indicate a trend of worsening with the treatment over what control is experiencing.

 

[AfroSnowman]

So is this good news or not? I'm extremely confused about all the talk on this thread.

Short answer, it sure looks like better news than was expected.

 

[ThomasF]

At the end of it all, I hope this leads to a permanent fix for tinnitus.

 

[Karen1979]

I am totally confused by that graph. There are purple dots in the upper left quadrant, at the very top.

Has someone in the trial had their tinnitus increase by more than 20 dB (1 unit is 6 dB) and at the same time had their TFI decrease by about 13 points (1 unit is 13 points)? Because those points are in the negative part of the TFI graph... I really don't understand it at all

I expected that no one would have an increase in volume. Personally, I can't imagine a worsening even by a 1 dB. I'm on the edge of my life. Are we going to take the risk?

Everyone, please give me your opinions, it really worries me. Thanks.

Scatter graphs are an ugly way to look at data.

But what they are showing are two variables and the relationship between the two. They are looking at a cause and effect relationship, how one influences the other, or how they are both influenced etc.

They can show three things:

1. Positive correlation.
2. Negative correlation.
3. No correlation.

Things to take from the graph:

1. There are more than 99 results on this graph, showing that the results were most likely taken over a period of time.
2. It shows positive correlation. Don't look at the dots look at the angle of the green and violet lines; the angle shows both are positive and this is what you want. Even the sham worked but the Violet line is steeper.

TFI is a poor indicator but I suppose it's a variable and they have used it in this graph to show the relationship.

If the two factors were loudness and time, the graph would probably have a much steeper and tighter set of results (they may even have this graph).

"I got 99 problems and this graph is one"