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Lenire — Bimodal Stimulation Treatment by Neuromod

#5,761
Chinmoku said:
The four possible outcomes of peer review are
  • Accept as is
  • Minor revision
  • Major revision
  • Rejection
Click to expand...
@Edward Viera received this email from Dr. Shore which seems to speak to her opinion of Neuromod's methodology. He posted it in the UMich thread awhile ago. I don't think she would word this email the way she did and her peer review fall within accept as is or minor revision categories, but what do I know.

BD8A4227-7D90-4062-B146-607DECCE5C4B.png
 
#5,762
GoatSheep said:
@Edward Viera received this email from Dr. Shore which seems to speak to her opinion of Neuromod's methodology. He posted it in the UMich thread awhile ago. I don't think she would word this email the way she did and her peer review fall within accept as is or minor revision categories, but what do I know.

View attachment 33689
Click to expand...
I think Dr. Shore just b-slapped Neuromod.
 
#5,763
GoatSheep said:
@Edward Viera received this email from Dr. Shore which seems to speak to her opinion of Neuromod's methodology. He posted it in the UMich thread awhile ago. I don't think she would word this email the way she did and her peer review fall within accept as is or minor revision categories, but what do I know.

View attachment 33689
Click to expand...
Yeah I got a similar email from her a few months back too. I remember I was curious about her thoughts on it.

She is doing the peer review, Neuromod has this disclosed on their website for sometime now, it's in the Phase IIb protocol document (https://www.lenire.com/clinical-studies). Yes the tricky part for them is the lack of a placebo group, which is exactly what Dr. Shore is hinting on. But with evidence of control through another method, in this case the results 12 months after treatment (long after any placebo would have worn off) this probably won't be too big of an issue. This appears to be the main thing Dr. Shore wants to scrutinize, which I think is a very good thing.

Though I agree they should have used a control group for one of the arms, when they already know a method works, I also kind of like that they used more randomized arms to evaluate which settings work best. I'm not exactly sure why they didn't choose to not do a placebo group, but I could imagine it's because they wanted to have as many participants as possible to try out the different settings and thus better find which is optimal.
 
#5,765
I respectfully disagree with Dr. Shore... just make it, sell it... and if someone gets a benefit from placebo or the science... who cares?

"Veruca Salt: Daddy, I want a goose! NOW!"

:cool:
 
#5,767
ChrisBoyMonkey said:
Yeah I got a similar email from her a few months back too. I remember I was curious about her thoughts on it.

She is doing the peer review, Neuromod has this disclosed on their website for sometime now, it's in the Phase IIb protocol document (https://www.lenire.com/clinical-studies). Yes the tricky part for them is the lack of a placebo group, which is exactly what Dr. Shore is hinting on. But with evidence of control through another method, in this case the results 12 months after treatment (long after any placebo would have worn off) this probably won't be too big of an issue. This appears to be the main thing Dr. Shore wants to scrutinize, which I think is a very good thing.

Though I agree they should have used a control group for one of the arms, when they already know a method works, I also kind of like that they used more randomized arms to evaluate which settings work best. I'm not exactly sure why they didn't choose to not do a placebo group, but I could imagine it's because they wanted to have as many participants as possible to try out the different settings and thus better find which is optimal.
Click to expand...
Doesn't it cost a lot of money for the appointment/trial to use Lenire?

I can't imagine, ethically or perhaps legally, that they could put some of those people in a placebo group?

Or have I confused this with some other trials/treatment?
 
#5,768
MichaelP said:
Doesn't it cost a lot of money for the appointment/trial to use Lenire?

I can't imagine, ethically or perhaps legally, that they could put some of those people in a placebo group?

Or have I confused this with some other trials/treatment?
Click to expand...
Lenire is no longer in trial phase, you now pay to get it.

The clinical trials were free for participants.
 
#5,771
ChrisBoyMonkey said:
I'm not exactly sure why they didn't choose to not do a placebo group
Click to expand...
Dr. Ross O'Neill discusses this in the Tinnitus Talk Podcast. It would have been impossible to create a convincing placebo device; the patients would figure out for example that there was no stimulation coming from the tongue tip which would ultimately compromise the placebo group.
 
#5,772
friend74 said:
It's getting serious for me now. Today I got an appointment date for end of April in Dublin.

A few days ago I wrote them a reminder. When they answered they also gave me an e-mail and postal address for Hannover. And they also said they have no influence on the assessment fees in Germany.
Click to expand...
I wrote an eMail to info@hoersys.de yesterday asking for details, costs, dates etc.
No reply yet.
 
#5,777
Ruse said:
Dr. Ross O'Neill discusses this in the Tinnitus Talk Podcast. It would have been impossible to create a convincing placebo device; the patients would figure out for example that there was no stimulation coming from the tongue tip which would ultimately compromise the placebo group.
Click to expand...
I've thought about it and couldn't they just use like a vibrating tongue tip instead? Or just ask Dr. Shore how she did it? Or maybe they did and she refused to advise them lol.

But what's done is done. I still think it was probably for finding the best settings. They could've found a way to do a placebo group if they really wanted to.
 
#5,779
JohnAdams said:
Uh, the people that it doesn't help?
Click to expand...
"and if someone gets a benefit from placebo or the science... who cares?"

How was S. Korea? ;-). Like you, I wouldn't care about all the studies and research to be ironclad.

Dr. Shore can do trials for the next ten years, and there will always be people that it doesn't help. If someone gets relief, the mechanism won't matter to that person. So all this testing for what? If there is no risk... then the efficacy in my opinion doesn't matter. I'll try her device yesterday. :)
 
#5,780
MRItechssuck said:
How was S. Korea? ;-). Like you, I wouldn't care about all the studies and research to be ironclad.
Click to expand...
Touché but I did a ton of my own research and it looked like a good shot.

With PRP, and other injections, stuff like IGF-1, neurotrophic factors, would enter my cochlea and possibly regrow synapses and other structures, in line with what some peer reviewed studies have shown.

With Lenire, I cannot even understand what the mechanism could possibly be. What is it even doing? What is wrong with our nerves and what does hearing a beep and zapping your DCN do to correct that?
 
#5,781
I got an appointment from Neuromod via email, and then got the confirmation text after sending them my information.

Do I need to reply to the text to get it confirmed past that?
 
#5,782
I would never knock anyone from trying anything to help themselves, and your S. Korea experiences have helped everyone gain insight into what is out there.

I am a little skeptical about the electrode/sound interaction. Logically I think the best cure is a drug into the ear to stimulate growth... everything else is just a band-aid or short term fix.

However, I would gladly buy and try that band-aid even though I don't understand how it's working. :)

Again, if this stuff won't electrocute someone or damage them.. .just throw it out there like every other previous failure and hope this one sticks. But the researchers want to know what is happening to build upon it... I realize that... but I'm impatient.
 
#5,785
JohnAdams said:
Touché but I did a ton of my own research and it looked like a good shot.

With PRP, and other injections, stuff like IGF-1, neurotrophic factors, would enter my cochlea and possibly regrow synapses and other structures, in line with what some peer reviewed studies have shown.

With Lenire, I cannot even understand what the mechanism could possibly be. What is it even doing? What is wrong with our nerves and what does hearing a beep and zapping your DCN do to correct that?
Click to expand...
 
#5,786
Good video... so dumb question... Dr. Shore has electrodes on the neck... Lenire has a tongue zapper... are they both stimulating the same nerves?

I still think they are trying to reprogram a computer without knowing its operating system.
 
#5,787
MRItechssuck said:
Good video... so dumb question... Dr. Shore has electrodes on the neck... Lenire has a tongue zapper... are they both stimulating the same nerves?

I still think they are trying to reprogram a computer without knowing its operating system.
Click to expand...
Well they both are getting something of a grasp on it. Dr. Shore has been researching it for over 15 years.

They are both targeting the Dorsal Cochlear Nucleus, Neuromod is using only the trigeminal nerve through the tongue to do it.

Dr. Shore is over the skin depending on where people can modulate their tinnitus.

"Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus."
 

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