University of Minnesota Tinnitus Research with Acoustic and Body Stimulation

[kelpiemsp]

It was supposed to be this August, no? kill me now.
What are they testing for phase 1, safety or something?
I'm holding my breath here guys.

It's actually in Phase-2. 24 of us enrolled. Phase three starts early 2019.

The reason it takes so long is that we are required to have 2 week washout period between each timing. Since no one knows the best timing yet. Then they have to do a study with the assumed best timing which requires another washout period between sessions to prevent mediating and/or compounding effects.

 

[threefirefour]

It's actually in Phase-2. 24 of us enrolled. Phase three starts early 2019.

Reason I said phase 1 was because that could cause confusion about the FDA system.

Kelpie's right, this is phase II, but unlike the susan shore device, this has to go through three phases because the first one wasn't adequate. This will be the first step toward the FDA approval process for the Minnesota team.

It was supposed to be this August, no? kill me now.
What are they testing for phase 1, safety or something?
I'm holding my breath here guys.

The Michigan phase II trial was supposed to begin in August, but it was held back. now it's anticipated to begin September or October. It will last for six months, into February or March. After that, and it clears FDA approval (probably about 4-6 months), then it can hit market.

 

[kelpiemsp]

What do you mean the first one wasn't adequate? As far as I understand this trial has been a linear progression, smoothly so far. I thought Michigan had the redesign? Admittedly @threefirefour follows this more closely than I do.

 

[threefirefour]

What do you mean the first one wasn't adequate? As far as I understand this trial has been a linear progression, smoothly so far. I thought Michigan had the redesign? Admittedly @threefirefour follows this more closely than I do.

It has but what I mean by that was that there wasn't enough people to fufil the requirements for a clinical trial by FDA standards, so they have to do three to make up for this.

So this is the second trial, but from the FDA standpoint, this is the first, technically speaking.

 

[Mathew Gould]

The Michigan research started years ago right? That thread is like 5 years old.

 

[JRC1]

Dear kelpiemsp, I am very interested in your story. Is your tinnitus still low? If so, how could you attribute the low tinnitus to anything other than the treatment you are receiving at U of M? I think you said you have had tinnitus for many years. Something seems to have caused it to change?

 

[kelpiemsp]

Dear kelpiemsp, I am very interested in your story. Is your tinnitus still low? If so, how could you attribute the low tinnitus to anything other than the treatment you are receiving at U of M? I think you said you have had tinnitus for many years. Something seems to have caused it to change?

It's at about 5 or 6 currently. I have two very distinct sounds. The one near and dear to my heart that I've had for 30 years and the new one I developed in February. One caused by surgery and trauma as a young child the other caused from most likely TMJ. I'm fairly/very health literate. It's clear to me I have inflammation and even had an mri that showed about a gulf ball sized effusion in my jaw joint pushing back. Not surprisingly, massive amounts of anti inflammatory medications help that inflammation and its corresponding Tinnitus. When I have a steroid treatment (iontophoresis) I notice a reduction in my new sound. I also notice an increase after overworking my jaw. When something decreases both sounds it's most likely effecting something in my brain. Thus, when I notice a reduction in both sounds, regardless of the status of my jaw, I can be fairly confident it's due to the trial.

 

[Benoves]

It's at about 5 or 6 currently. I have two very distinct sounds. The one near and dear to my heart that I've had for 30 years and the new one I developed in February. One caused by surgery and trauma as a young child the other caused from most likely TMJ. I'm fairly/very health literate. It's clear to me I have inflammation and even had an mri that showed about a gulf ball sized effusion in my jaw joint pushing back. Not surprisingly, massive amounts of anti inflammatory medications help that inflammation and its corresponding Tinnitus. When I have a steroid treatment (iontophoresis) I notice a reduction in my new sound. I also notice an increase after overworking my jaw. When something decreases both sounds it's most likely effecting something in my brain. Thus, when I notice a reduction in both sounds, regardless of the status of my jaw, I can be fairly confident it's due to the trial.

How loud was your tinnitus before? When you mention it's now a 6.

 

[JRC1]

Thank you for your response. Many people are following your experience. One more question at present - if your T is currently 5/6, what would it normally be before you began the trial? Thank you again.

 

[kelpiemsp]

Thank you for your response. Many people are following your experience. One more question at present - if your T is currently 5/6, what would it normally be before you began the trial? Thank you again.

It's very hard to answer this question appropriately for this audience at this point. Mainly because they are testing different offsets to find which one is most effective, and then apply that theory with my EEG to see what happens. However, much of this is blind to me. So, it can provide false skepticism if I say "I had no change". This is because its entirely possible I received either a sham, or a timing that doesn't work well for me. That being said, I had a session (3 fridays ago or so, where I received for the first time, something that was real, quantifiable, and definitely lowered my T. I felt this gave a drop of around 5-7 Db. My T had been about a 7-8 in the early parts of the trial.

 

[kelpiemsp]

How loud was your tinnitus before? When you mention it's now a 6.

It took about 85 DB to match. I rated that a 7-8.

 

[Benoves]

It took about 85 DB to match. I rated that a 7-8.

It's very promising to hear that something is happening. It makes me more confident along with some of the drugs researchers going on that we will have some form of treatment in the future to lower the ringing. It doesn't have to go away but if it can be reduced to some more manageable levels that would be nice. I'm hoping you get a better timing this Friday!

 

[Mathew Gould]

A lot of people get spikes from eating certain foods, drinking alcohol and weed. Say this device or another device eliminate people's tinnitus, do you think if that person consumed the above the tinnitus would slightly come back or spike?? Opinions please.

 

[Mathew Gould]

It took about 85 DB to match. I rated that a 7-8.

Could you explain this better, what do you mean it took 85 dB's to match?? A vacuum is almost 85 dB's, does that mean your tinnitus is as loud as a vacuum?

 

[kelpiemsp]

Could you explain this better, what do you mean it took 85 dB's to match?? A vacuum is almost 85 dB's, does that mean your tinnitus is as loud as a vacuum?

That means it takes the same level of noise as a vacuum to mask my T.

 

[noitseuq]

That means it takes the same level of noise as a vacuum to mask my T.

I think I'm on the same level on masking. Sadly.

What are you thoughts for now of this trial?

 

[Stakovic]

@kelpiemsp
Any updates?

 

[noitseuq]

@kelpiemsp
Any updates?

Or @Tripstan ?

 

[kelpiemsp]

Hi all just an update. I received the -15 timing, and I have to say I had the quietest weekend since this spike started. I even took a nap without masking. Anyways, it's slowly coming back, but it's not as loud as before. Plus I have done a few things that should have aggravated it (long bike ride, mowed lawn, saw a concert) This reduction has been 7-10 dB. I am very much looking forward to the next study where I can wear it every day. It might just be my evening peak (it tends to be a bit louder at night) I had my doubts immediately after the trial, but in my experience this plasticity takes time. For what its worth I experienced a couple firsts (since my new spike started) this weekend: sleep without masking, sleep with my ear against a pillow, and go like 3 hours with silence. That was pleasant.

 

[threefirefour]

Hi all just an update. I received the -15 timing, and I have to say I had the quietest weekend since this spike started. I even took a nap without masking. Anyways, it's slowly coming back, but it's not as loud as before. Plus I have done a few things that should have aggravated it (long bike ride, mowed lawn, saw a concert) This reduction has been 7-10 dB. I am very much looking forward to the next study where I can wear it every day. It might just be my evening peak (it tends to be a bit louder at night) I had my doubts immediately after the trial, but in my experience this plasticity takes time. For what its worth I experienced a couple firsts (since my new spike started) this weekend: sleep without masking, sleep with my ear against a pillow, and go like 3 hours with silence. That was pleasant.

This.is.awesome!

 

[Mathew Gould]

Hi all just an update. I received the -15 timing, and I have to say I had the quietest weekend since this spike started. I even took a nap without masking. Anyways, it's slowly coming back, but it's not as loud as before. Plus I have done a few things that should have aggravated it (long bike ride, mowed lawn, saw a concert) This reduction has been 7-10 dB. I am very much looking forward to the next study where I can wear it every day. It might just be my evening peak (it tends to be a bit louder at night) I had my doubts immediately after the trial, but in my experience this plasticity takes time. For what its worth I experienced a couple firsts (since my new spike started) this weekend: sleep without masking, sleep with my ear against a pillow, and go like 3 hours with silence. That was pleasant.

This is supposed to work for all people with tinnitus right... I have re-active tinnitus that gets louder with sound, should this timing device work for that??

 

[Mathew Gould]

This.is.awesome!

When's the next study??

 

[threefirefour]

When's the next study??

Friday after next as usual. Unless you mean next phase, which is early 2019.

 

[Mathew Gould]

Friday after next as usual. Unless you mean next phase, which is early 2019.

Okay, every other two weeks... I need this device, I'm sick of hearing this static noise in my brain... When he gets to wear it all the time, we need pics.

 

[Benoves]

Is the 7-10 dB reduction in addition to the earlier reduction?

 

[kelpiemsp]

Is the 7-10 dB reduction in addition to the earlier reduction?

No all reductions are compared to my baseline when I first started. Generally the belief is that the effects last no longer than 2 weeks (that is why the washout) in my experience that has been true.

 

[Benoves]

No all reductions are compared to my baseline when I first started. Generally the belief is that the effects last no longer than 2 weeks (that is why the washout) in my experience that has been true.

Thanks for answering. You are a hero updating us. Do you feel that it can improve more once you get the treatment more frequently?

 

[kelpiemsp]

Thanks for answering. You are a hero updating us. Do you feel that it can improve more once you get the treatment more frequently?

Ha thanks I really don't know, it makes sense, but T is so hard to make sense of. I believe that will be the focus of the final trial next year.

 

[kelpiemsp]

A lot of people get spikes from eating certain foods, drinking alcohol and weed. Say this device or another device eliminate people's tinnitus, do you think if that person consumed the above the tinnitus would slightly come back or spike?? Opinions please.

In my opinion it's like a -10db tinnitus ear plug lol. Lots of people have a low volume T. Say your T is so quiet you have to have ear plugs in...and then it raises 2 db. You would never hear it. Remember, I have only had -15 ms timing once. But in my experience it's just a -7-10db on whatever your T is or would be. Does that make sense?

 

[Stakovic]

@kelpiemsp,
was it your last session in this year?