MuteButton

That seems an unnecessarily aggressive statement.

I'm not suggesting that someone would withhold a cure, especially because none of the things we're discussing are cures. It's a comment on the system; they plan things to last for the duration of the funding, if they have 4 years then they plan the stages to fit into that. There isn't anything evil about it.

 

Hi @Steve,

Any updates?

 

Maybe evil is too strong a word. But I just don't understand what the hold up for the different technologies that could help us is all about.

If they have something that can help us then they need to act with urgency. This point is why there was a need for right to try laws, to bypass red tape and potentially help people, faster. This is supposed to be about helping people.

 

Me anxiously waiting @Steve's MuteButton update lol

 

Nothing received yet - I promise as soon as I hear I will post.

But this law is for terminal patients as I understand it? I know that it's frustrating, I feel it too. The thing is that if the research isn't done in a robust way it could potentially block off or throw things back in an entire field that has promise.

 

Right but the spirit is still the same. Tinnitus makes people suicidal, suicide is fatal.

I also don't see the big deal. It's not dangerous.

How many drugs have been approved that are ototoxic and cause tinnitus in the first place?

I feel like they owe it to us to go much much faster.

 

Just joking here @Steve! I know you have to wait for them to get in touch.

 

I received a reply yesterday evening. They are looking at the date for Q&A, slightly delayed on that because they are travelling all over the place with presentations right now.

I promise to pin them down as soon as I can though

Their response:

Dear Steve

We are very encouraged by the enthusiastic response to the news that we have begun the process of scientific dissemination of the results of the TENT-A1 clinical trial.

Neuromod is committed to being open and transparent in all of our clinical activities. Thus, Neuromod has worked closely with scientific advisors to design the protocol for TENT-A1, and published the protocol in the BMJ Open to ensure that all patients and health care providers could read the study design in advance of completion. Neuromod has committed to sharing the results of the trial in a forum that has been subject to peer review, so that patients and their clinicians can have confidence in the results.

The last patient completed their 12 month follow up visit in the TENT-A1 clinical trial on June 4th, 2018. The data has been collated and analysed in line with pre-defined analyses and in accordance with a pre-specified statistical analysis plan. Prof. Hubert Lim is finalising the clinical summary report that he will submit for publication to a well-recognised and highly-regarded peer-reviewed publication. Prior to publication, Prof. Lim will ensure that all of the authors have reviewed and signed off on the publication (including our Scientific Advisory Committee of Prof.s Berthold Langguth, Sven Vanneste and Deborah Hall). Prof. Lim expects to complete this process soon but no later than the end of 2018. While the peer review process is outside of Neuromod’s control and can take 3 to 6 months on average, Neuromod is hopeful that the publication will be available in the first half of 2019.

In order to preserve the scientific integrity of the peer-review process, Neuromod has not yet publicly announced the final results. Neuromod has disclosed high-level preliminary results at audiology, medical and tinnitus conferences in the US and Europe. Presenting high-level preliminary data at Academic and Scientific Conferences is an important step in ensuring that the data is available for scrutiny by clinicians in parallel with the peer-review process.

We understand that there is impatience to see the final results of this large and important study, and we are committed to making the results widely available through reputable and well respected journals as soon as possible.

In the meanwhile, we would like to direct attention to the following open access reports and information sources:

• https://clinicaltrials.gov/ct2/show/NCT03530306
  
• https://clinicaltrials.gov/ct2/show/NCT02669069
  
• https://www.neuromoddevices.com/con...dvancement/phase-i-safety-and-feasibility.pdf
  
• https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

We are working hard to bring a meaningful new option to tinnitus patients that is backed by scientific and medical integrity.

Thank you for your continued patience

The Neuromod Team​

 

Thanks for the update @Steve

 

@Steve,
Thank you for the update.
Love glynis x

 

Lucky Bastard!

So timeline wise, does this mean the results of the peer review and official publication won't happen till mid 2019? Do they also have to seek "FDA" approval in Europe, Ireland, & US after that or can they start seeking it now?

Is there a stronger word for impatience?

This is good to know. The more reputable and more well respected the harder it is to get published in so the results have to be legit.

This is all we can really ask for tbh.

Anyone got extra patience I can borrow?

@Steve thanks so much for the update, you truly are a saint. The memes I post are just in jest to bring some humor to the situation. I know you're working hard for the community! Very much looking forward to the Q&A. Thanks again!

 

Attached is the abstract from the Neuromod presentation last week at the AAO Conference in Atlanta, Georgia, USA. It validates what they have told @Steve, they are keeping the presentation high level.

Some of the people in these audiences where Neuromod and company are making presentations could be among the "peers" that will review the journal article. So getting them familiar with this new area may actually facilitate the peer review process in the long run and could ease acceptance of the device when it comes to market.

The TENT-A study is an exploratory study. In addition to @Jack Straw's questions, you might want to ask Neuromod if they will need to do an additional study or studies to confirm the exploratory results if they are positive.

I scanned the protocol for the TENT-A study and they have "powered up" on the sample size. That's a common practice in an exploratory study so when the results come out, be sure to ask yourself whether or not a statistically significant difference is also a clinically significant or a clinically meaningful difference.

You can also ask if the statistical analysis of the data in the exploratory study would be acceptable for submission to a regulatory authority. Sometimes, but not always, exploratory analyses allow for more looks at the data to find the parameters that are near or at significance. Not quite data mining but different from a pivotal study where if the primary outcome is not statistically significant, no further analyses are done and the study is not supportive.

I don't have somatic tinnitus so have not followed these devices that closely. But, I hope for all that do, that there is a good result!
TC

 

I have not heard anything about Neuromod only being for somatic tinnitus or only being tested on somatic tinnitus. I know one in the US is only being tested on somatic tinnitus patients, but that doesn't mean it is only for them.

 

That’s implied because it is using a somatic pathway.

 

So all these devices are for only treating somatic tinnitus? That's very unfortunate.

I thought this device was using the vagus nerve, if that makes any difference?

 

No that’s not how to read it either. These devices should work on about 80% of tinnitus.

 

Neuromod's Twitter account has been posting for days about how they are touring European conferences "presenting positive 12-month data from our 326 patient double blind randomized clinical trial."

Does anybody have any insight into just what this information is?

The publication MedTech Strategist from September 14, 2018 has a pretty glowing article about it.

I'm curious if this is misplaced hype.

 

Hello and welcome!

They recently just updated our director @Steve with some information. He will be doing a Q&A in the future. They can't post their results because they are going into peer review, but I doubt they would be going through this process if it didn't work.

Here is Steve's post:

 

How do you know that?

 

Good news!

A side note, I always thought your picture was of your dog in the woods with beautiful colors and trees around it. Upon clicking it I realize it's a fence and now I can't unsee it!

 

@katri @Jack Straw
The current theory is that 80% of tinnitus travels through the DCN. Either through the otic pathway, or the somatic pathway.

Bi-Modal Stimulation hopes to use these pathways to achieve tinnitus reduction.

As you can see, the theory holds that otic and somatic travel through the DCN, while some otic does not.

I hope this explains things better.

 

It helps but now I’m just scared that I’m not included in the 80%. I’m not a lucky person at all and I’m struggling a lot as of late.

 

I feel the same way, but 80% is pretty good. There are also 3 devices so if one doesn't work another might!

 

What are the other ones?

 

WTF! Me too Illusion RUINED!

 

Thank you for this!

 

One is Susan Shore and the other is University of Michigan I think.

 

• Susan Shore = University of Michigan
• University of Minnesota
• Neuromod

 

Susan Shore is Michigan, the other one is University of Minnesota .