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Pleasure_Paulie

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 #1 
Hi Doctor,

Firstly - thank you for your forum.  It's fantastic we have the opportunity to speak to somebody who is not only medically qualified, but who intimately understands tinnitus.  It sure beats those "google" and internet doctors! 

Anyway to my question...

On the surface, rTMS appears to be a highly studied area of treatment for tinnitus.  A search alone on clinicaltrials.gov https://clinicaltrials.gov/ct2/results?cond=Rtms+Tinnitus&term=&cntry1=&state1=&SearchAll=Search+all+studies&recrs= reveals over 14 studied (some completed and some ongoing).  There is many other articles, and clinical studies performed on the topic which I'm sure you've probably already read :) 

Now obviously all studies reliability depend on the robustness and how these were conducted (are they double blinded, randomised placebo for example?!).  And potentially many of the studies on topic may not be worth the paper they can be printed on, but there appears to be an overall pattern forming that rTMS does show efficacy over the placebo (albeit around a 50% improvement rate).  

Being acutely aware of my own confirmation bias thus attempting to be impartial and open minded on the topic as possible, I ask you based upon what you've written on these forums:

Why do you have the cynicism on rTMS as a treatment for tinnitus now and moving forward? 
 
Dr. Nagler

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 #2 
Paulie asked:

Why do you have the cynicism on rTMS as a treatment for tinnitus now and moving forward?

It's not exactly cynicism; I would rather call it a healthy skepticism. And my healthy skepticism extends way beyond rTMS to any approach that sounds too good to be true. Maybe part of it has to do with my frustration with the seemingly snail-like pace of tinnitus research. Indeed, part of it has to do with the fact that the research community has yet to agree on what exactly tinnitus is! Looking specifically at rTMS, however, in spite of what might appear to be a considerable number of studies, quoting that Wendy's commercial from the mid-1980s, I keep asking myself, "Where's the beef?" Even your own reference to "around a 50% improvement rate" sort of glosses over exactly how "improvement" is defined, not to mention how long it lasts.

Here's what I would like you and (anybody else reading this post) to keep in mind: In the final analysis my opinion with respect to rTMS, etc. has absolutely no prognostic value whatsoever. In other words, these treatments will ultimately stand or fall on their own merits, and what I happen to think about any of them at this point in time is totally irrelevant in that regard.

Stephen M. Nagler, M.D.
Atlanta Tinnitus Consultants, LLC

__________________

The best way to find yourself is to lose yourself in the service of others.
- Mahatma Gandhi
Pleasure_Paulie

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 #3 
Thank you for your reply, Doc.  In response to a few things you've said.

"Maybe part of it has to do with my frustration with the seemingly snail-like pace of tinnitus research.

You've been around longer than me, but the field of hearing loss and tinnitus is thriving.: Frequency Therapeutics, Auris Medical with AM-101 are recruiting for their final clinical trial which could be the first treatment for acute tinnitus on the market with Otonomy releasing a similar NMDA receptor antagonist.  This does not include the other work being made with stem cells, gene therapy and Xenon pharma is working on an improve version of Trobalt hitting clinical trials soon.  There is much more, and while much of this won't see the light of day - some of it just may.

In regards to audiological techniques there is many clinical studies being done on neuromonics, acoustic neuromodulation and notched sound therapies.   

There has been improvements with brain imaging and the ability to capture what parts of brain are overactive in a tinnitus patients in order to development treatments.  Additionally there is been much research into what causes the tinnitus to "stick" proceeding an acoustic trauma. 

"Where's the beef" 


http://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2388777
 "18 of 32 participants (56%) in the active rTMS group and 7 of 32 participants (22%) in the placebo rTMS group were responders to rTMS treatment. The difference in the percentage of responders to treatment in each group was statistically significant."

http://journal.frontiersin.org/article/10.3389/fneur.2017.00126/full
"Almost half of the patients (12 of 25) reported immediate tinnitus reductions during the test session. In this group, the mean pre- to post-treatment amelioration in the tinnitus questionnaire was higher (medium to high effect sizes) in contrast to the patients who did not respond to the test session. Treatment outcome remained stable over a follow-up period of 10 weeks." This is particular importantly and shows results were sustained at a 26 week checkup. 

I attached a supplementary attachment. As stated above, this is an area of study with considerable interest. 

In the final analysis my opinion with respect to rTMS, etc. has absolutely no prognostic value whatsoever.

I beg to differ.  You're an MD, and an MD that deals with Tinnitus in his personal life and professional life.  You should have an opinion and perspective on potential treatments for your patients and people you give advice to on this board.  In other words, you should be at the leading edge of research and treatments.  


 
Attached Files
pdf OOI150045supp2_prod.pdf (92.61 KB, 3 views)

Dr. Nagler

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 #4 
Paulie, I came very close to disallowing your post directly above because this is a Question and Answer board, and the post contained not a single question. Folks (presumably including you) who come here do so because they have questions, and they want to hear what I have to say on the issues that concern them. Try to keep that in mind. This board is not a tinnitus discussion site. If you wish to discuss or debate, please do it elsewhere.

So very briefly ...

Quote:
Thank you for your reply, Doc.  In response to a few things you've said.

"Maybe part of it has to do with my frustration with the seemingly snail-like pace of tinnitus research."

You've been around longer than me, but the field of hearing loss and tinnitus is thriving.: Frequency Therapeutics, Auris Medical with AM-101 are recruiting for their final clinical trial which could be the first treatment for acute tinnitus on the market with Otonomy releasing a similar NMDA receptor antagonist.  This does not include the other work being made with stem cells, gene therapy and Xenon pharma is working on an improve version of Trobalt hitting clinical trials soon.  There is much more, and while much of this won't see the light of day - some of it just may.

In regards to audiological techniques there is many clinical studies being done on neuromonics, acoustic neuromodulation and notched sound therapies.   

There has been improvements with brain imaging and the ability to capture what parts of brain are overactive in a tinnitus patients in order to development treatments.  Additionally there is been much research into what causes the tinnitus to "stick" proceeding an acoustic trauma. 

What I said is that in my opinion tinnitus research is moving at a snail's pace. And I will stand by that statement. The fact that there may be a number of snails in the forest does not change the fact that the pace is slow. Moreover, many of the studies to which you refer are seriously flawed. Does that rule out the possibility of some sort of extraordinary breakthrough? Of course not. Pipe dreams can come true. All I am saying is that I wouldn't count on it. You are free to disagree to your heart's content - just not here, OK? Because like I said, this is not a discussion board.

Quote:
"Where's the beef" 

http://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2388777
 "18 of 32 participants (56%) in the active rTMS group and 7 of 32 participants (22%) in the placebo rTMS group were responders to rTMS treatment. The difference in the percentage of responders to treatment in each group was statistically significant."

http://journal.frontiersin.org/article/10.3389/fneur.2017.00126/full
"Almost half of the patients (12 of 25) reported immediate tinnitus reductions during the test session. In this group, the mean pre- to post-treatment amelioration in the tinnitus questionnaire was higher (medium to high effect sizes) in contrast to the patients who did not respond to the test session. Treatment outcome remained stable over a follow-up period of 10 weeks." This is particular importantly and shows results were sustained at a 26 week checkup. 

I attached a supplementary attachment. As stated above, this is an area of study with considerable interest. 

"Considerable interest" is wonderful. But you cannot put it into a pill or a magnet with the legitimate expectation that in so doing there will be a cure for tinnitus. Maybe in ten years. Maybe in twenty. Maybe in a hundred. Maybe never. But for sure not today. However today we do have a number of effective ways to achieve meaningful lasting relief through habituation. And that is where my interest lies.

Quote:
"In the final analysis my opinion with respect to rTMS, etc. has absolutely no prognostic value whatsoever."

I beg to differ.

You beg to differ? Really? Look, either rTMS will be the holy grail of tinnitus or it won't. That is the reality: either it will or it won't. You think that my opinion that rTMS will likely go nowhere will in some way affect that reality? Goodness, if I had that sort of prognostic power, I'd spend my time at the racetrack betting on horses I believe will win. And I'd become a gazillionnaire because my opinion that they will win will make them winners in actuality.

Quote:
You're an MD, and an MD that deals with Tinnitus in his personal life and professional life.

I no longer "deal with" tinnitus in my personal life because thanks to TRT I have habituated it. So I still have tinnitus, but I no longer have any need to deal with it. And as far as my professional life goes, I have chosen to devote my efforts to assisting others in overcoming their tinnitus as I have overcome mine. If that is some sort of crime, then I am guilty as charged. 

Quote:
You should have an opinion and perspective on potential treatments for your patients and people you give advice to on this board.

I do have an opinion and perspective on potential treatments. Apparently you do not like that opinion, and quite frankly nothing would make me happier were I to discover one day that you are right and that all this time I have been wrong.

Quote:
In other words, you should be at the leading edge of research and treatments.

Why? Because you say so? Look Paulie, I have chosen to leave the "leading edge" to folks who are much smarter than I. Me? If my socks match when I walk out the door in the morning, I figure I'm already ahead of the game. And if I can make some small difference in the life of even one tinnitus sufferer before dusk, I call it a very good day indeed.

Now I am going to respectfully ask you to leave this topic alone. Let's just agree to disagree.

Stephen M. Nagler, M.D.
__________________

The best way to find yourself is to lose yourself in the service of others.
- Mahatma Gandhi
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Dr. Nagler's Tinnitus Corner is provided for education and information only. It is not intended for the purpose of providing medical care and should in no way substitute for appropriate in-person consultations with qualified healthcare professionals. By using this site, participants agree to hold Dr. Nagler and Atlanta Tinnitus Consultants, LLC harmless with respect to any loss, injury, claim, liability, or damage arising from following the postings herein.