New University of Michigan Tinnitus Discovery — Signal Timing

Damn, I’m out of the trial zone by like 80 miles.

 

Maybe you can ask if they would include you anyways? If you'd be willing to make the drive.

 

Where are you Cleveland? Akron?

I'm in Columbus. They already refused me for Clonazepam but I guess I wouldn’t have qualified anyway cause I’m the same distance outside the zone.

 

Cuyahoga Falls, right next to Akron. I’ll give it a shot.

 

Good luck!

 

Just sent this to the contact provided. If you guys need her email it’s gerjones@umich.edu

Dr. Jones,

I understand that an inclusion criterion for the bi-modal stimulation study requires one to live within 100miles of Ann Arbor. I am a little out of this range as I live in northeast Ohio, but would be more than willing to make the drive to see if Dr. Shore’s treatment would be effective in eliminating what I consider the biggest problem of my life. I urge you to consider my eligibility for participation.

Thanks,

Jackson

 

You'll be in my prayers. We all deserve some relief from this nightmare.

 

I will be going Tuesday to the 2 hour eligibility screening.

 

Good luck! I hope they accept you and you find some real relief.

 

Bad news. Do these people think the participants who can get to sleep without the need for significant medication are really the same ones who are pounding on the door for relief? I mean, fuck. I get the Clonazepam neuroplasticity argument but I’m sorry... their pool of participants have to be baby-soft about their mild tinnitus.

 

Dang. I'm sorry to hear that.

They do sound a little too strict on their drug exclusion.

 

Are they looking for people with long term or short term < 6 months tinnitus?

So no drugs, and within 100 miles... bilateral or unilateral tinnitus?

I wish they would just have you sign a waiver and let anyone try it.

 

To mrbrightsided164:
Your comments are very much on point.
The only option for many of us has been to see a psychiatrist, who of course would prescribe something.
The only reason many of us have been able to refrain from being horrifying suicidal has been because various medications have at least partially neutralized our rage/panic reactions.
Given (in my opinion) these wholly unnecessary, fastidious elegibility requirements, I am suspicious of just how effective this will be for all of the widely varying types and states of reported tinnitus situations.
Once again, two years ago our Chicago Tribune had an article in the Health and Wellness Section about this treatment.
These clinical trials have been, to say the least, conducted at an incomprehensibly sluggish pace.

 

I understand but there is severe sufferers without medications. I don´t take benzos or sleeping pills and my tinnitus is usually horrible. I can sleep well even with the unmaskable ringing. Anyway mine is not somatic and I don´t live in the US. :S

 

I agree 100% and am absolutely losing faith in this device the longer this gets dragged out.

Sure, I meant no disrespect. Still, I am apprehensive about these devices’ utility in more chronic cases such as yourself. So I’m really unsure of who their target demo is here.

 

To MRltechsuck and MrBrightside 164:
I also wonder why Dr. Shore is not considering subjects who have been on medication as a means of further extending the clinical trial discoveries and results.
If I were her I would be interested in determining what different results (if any) accrued from clients who were on all sorts of long term medications. Might this actually augment the process?
I recently read that last year one out of every twelve Americans was prescribed an antidepressant (and this does not include other psychoactive drugs).
If this treatment under such circumstances will not be effective, then it reduces the scope of eligible patients to a very substantially small fraction of the total sufferers.

 

Luckily, I doubt the clinical criteria here will preclude patients from access once she commercializes her device. I know that’s not what you’re implying here, and that you raise a good point regarding the broadening of the participant pool strengthening research applications. And yes, a shit ton of people are on different things just to scrape by. Why are Shore et al. so puritanically deluded? Both seroquel and remeron increase BDNF, which I realize is only one facet of cognitive modulation but really, get real here. You could point to MILLIONS of different variables that could confound research results for any given study. This is not the hill to die on.

 

This is what I got today...

“Although we are still actively recruiting subjects for our pivotal FDA clinical study, and I appreciate your interest in participation, our inclusion criteria requires that participants reside within 100 miles of the study site. The protocol stipulates that participants come to the study site for weekly visits and evaluation during the 6 month treatment period. Excessive travel for a long period of time can negatively affect tinnitus, since we are in the early stages of the trial we have stricter criteria to eliminate outlying factors. We may be changing our criteria in the future to include those a little further away and those who travel more regularly.

I will note your file to contact you again once we expand our criteria.“

 

I agree! For some people, benzos make it worse.

 

https://news.ohsu.edu/2017/08/22/study-suggests-serotonin-may-worsen-tinnitus

This is probably why they are excluding serotonergic drugs.

I know for myself seroquel gave me the worst spike I’ve ever had. All other serotonergic drugs I’ve taken have also spiked me.

 

When is this shit hitting the market?

 

Strange. I wonder how you’d respond to citicoline and triacetyluridine (both cognitive enhancers) if you respond poorly to ACh/D2 receptor blockers.

 

Just give her another 20 years okay jeeze.

 

With fast track and now the right-to-try legislation in the US... this isn’t a drug... it’s an iPod on steroids... or one of those electric stick/massage machines from QVC... what needs to be approved??

It’s a little more complex than Suzanne Somers’ thighmaster, sure... but it’s not a drug... and non-invasive.

Rant over.

 

Oh really Dr. Shore! You're going extend the distance from your testing site? In another trial maybe? Another two years down the road? How lovely! We're all so terribly excited. No need to rush now. Isn't permanent tenure just so peachy?!

 

Exactly what I was thinking, every single day is a struggle for us.

I'm hoping that doesn't necessarily mean 2020 commercialization is ruled out though.

After reading that a second time, they might mean criteria in this study. It's possible, updates like that have happened.

 

If she's so worried about travel, make the devices in China for 10 cents and mail them out for God's sake.

All these people are so damn blind. Have a pool of us who don't meet your perfect criteria but want to try anyway and let us try. Our results can be extra info for the study. It either works or it doesn't.

I'm sorry, but this woman is lost in space if you ask me. I appreciate what she's done, but now she's just milking things.

 

To MRltechssuck, Rb86, Mrbrightside164:

Given the demand, I can't believe that no one (including Dr. Shore) has recognized the clear potential for speedily acquiring hundreds of thousands in revenue from the release of this.
There are also all sorts of electrical stimulation devices on Amazon that do not require FDA approval.

Coupled with a Desyncra-like tonality (and they had no roadblocks in securing FDA approval), this should be a completed product.

At this rate, will Lenire be available in Chicago before this is released?

I was even considering a do-it-yourself kit: I would study an anatomy manual and have several wires with adhesives attached to various parts of my head and neck from a pulsating dry cell battery along with I pod headphones (just kidding).

 

So she might expand in the future? what happened to “moving can worsen tinnitus?”. If that’s your assertion (which I think is silly) why would you then turn around and say “welllll guess we could let off on the moving criteria a bit later on”.

Like which is it?? And what happened to their IRB saying that moving/travel was off the table? So it is a stipulation that can be renegotiated? I’m so confused...

Susan Shore I love you, but you make me so tired. Just commercialize the damn thing already.

 

Far enough in the future that it probably serves no purpose to even ask.