It says that I don't have the right clearance for it all tho. I guess you have to be an ENT or medical professional and I can't lie on that.
MuteButton
- Thread starter Jim
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MemberThey might make an announcement anyway because that's how we learned about FX-322 going to phase 1b. They made the statement at the US-Japan Symposium on Drug Delivery on December 17, 2017 . The Business Wire reported the continuation December 21st.
Seems like we're at a dead end here. We can only hope Neuromod posts it online somewhere. I apologize for getting everyone's hopes up about today.
I'll try to update everyone if I find something.
I'll try to update everyone if I find something.
They blocked you when you tweeted at them?I tweeted them to ask about the trial data. They deleted my question.
What does this mean?
Thank you for the update, you have lifted my spirits! I do hope that they will release it sooner than later. "In preparation" can be a while, but it's better than nothing.Chill, friends
Someone else asked this question and their Tweet is up:
View attachment 22977
@Stakovic @Jack Straw
FounderThe "in preparation" is a little vague - if it's still in fact being written, and not submitted to a journal, it can potentially take many more months until the results are published. The peer reviewing process can be extremely slow, especially if the reviewer(s) ask to make any changes to the article before publication, the back and forth can take quite a while.
Duration and quality of peer review process
Table 2 shows that the reported total review duration of accepted manuscripts is on average 17 weeks. Again there are substantial differences between scientific fields. With 12–14 weeks, average total review duration is shortest in Medicine, Public health, and the Natural sciences. It is longest in Economics and Business, where the process takes on average 25 weeks and is twice as long.
Table 2 shows that the reported total review duration of accepted manuscripts is on average 17 weeks. Again there are substantial differences between scientific fields. With 12–14 weeks, average total review duration is shortest in Medicine, Public health, and the Natural sciences. It is longest in Economics and Business, where the process takes on average 25 weeks and is twice as long.
At the Expo it was stated to many of the visitors (IIRC) that the device is going to be released by the end of 2018 or at the beginning of 2019 in Ireland / Europe. I would assume it will be published before then?
Maybe @Steve can shed some light since he talked with them?
This is very important @Steve as this is what they did in phase I.
42% reduction based on a "Paper" that was being produced... It was never produced...
If they go to sell this again without an academic study produced - I will personally go on Radio/TV and discredit them.
I'm on LinkedIn with Ross O'Neill - I'll ask him what the story is.
Ross O'Neill
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- Robert Clancy 12:27 AM
Hey Ross. Thanks for Linking In. There's a lot of excitement going on right now regarding the Mutebutton II. The results of the Double Blind Trial seem amazing. I want to thank you for your work to date in trying to find a treatment for this terrible affliction. As we have now seen with Susan Shore you are on the right track. Anyways thanks for flying the flag for Ireland in what could literally be the medical breakthrough of the last 60 years. Very best of luck. R
- Robert Clancy 11:42 PM
Hi Ross - Folk are looking for the journal publication of the results today. You know when that will be? R
Here's the direct link to the webcast (in case someone reading this happens to have access):
Neurostimulation Approaches for Treating Tinnitus: Novel Stimulation Paradigms, Patient Subtyping, and Mechanisms of Action: Part I and II
Description
Over the past decade, there has been increasing interest and developments in neurostimulation approaches for treating various health disorders.
A new and rapidly evolving area of neuromodulation is the use of cranial nerve stimulation to activate or modulate the brain to reverse pathological activity, such as occurs with tinnitus.
Novel noninvasive neurostimulation approaches, including transcranial magnetic stimulation and transcutaneous electrical nerve stimulation, are also providing alternative ways to modulate brain regions involved with tinnitus for therapeutic outcomes.
Tinnitus affects approximately 5% of the population, yet there are limited or unpredictable treatment options for patients. Therefore, tinnitus poses a major clinical challenge for the otolaryngology field. This international symposium will highlight recent advances in neurostimulation that offer new tools and technologies for the otolaryngology field to tackle tinnitus.
Leading international clinicians and scientists will present on a variety of topics including approaches using cochlear implant stimulation, implantable vagus nerve activation, trigeminal tongue stimulation and cortical magnetic stimulation for tinnitus treatment.
Novel bimodal stimulation paradigms and tomographic neurofeedback methods are also being developed for driving greater or more targeted plasticity in the pathological brain. Together with improvements in patient subtyping (e.g., predictable responders with cochlear implant treatment), these neurostimulation approaches can provide more effective and reliable solutions for tinnitus patients.
Learning Objectives:
- 1. Explain trends and new directions for tinnitus treatment and patient subtyping relevant for informing clinicians and tinnitus patients.
- 2. Compare different technology features and neural mechanisms involved with neuromodulation and brain plasticity for treating brain conditions such as tinnitus.
- 3. Interpret different tinnitus outcome measures used for evaluating treatment efficacy and mechanisms of action.
Faculty:
- Hubert H. Lin, PhD (Stock or Stock Options; Salary: Neuromod Devices Limited, Research funding: NIH, NSF, DARPA, Minnesota, Lions; Leadership Role: Neuromod Devices Limited; University of Minnesota)
- Thomas H. Lenarz, MD, PhD (Nothing to disclose)
- Tobias Kleinjung, MD (Nothing to disclose)
- Paul Van de Heyning (DISCLOSURE)
- Sven Vanneste (Nothing to disclose)
- Brendan J., Conlon, MBBCh, FRCSI (DISCLOSURE).
- Apr 18, 2013
- 1,633
- Tinnitus Since
- 2003
- Cause of Tinnitus
- Flu, Noise-induced, Jaw trauma
Hi. Bi-modal stimulation is in a way different place to when they released the first device, I remember laughing at it a bit when it first came out. The approach is definitely legit, it's corroborated in more than one study outside of this device.
The main thing now is for the results to come out, for corroboration by Susan Shore of the approach and also from others who are looking at brain stimulation combined with another treatment technique. I don't see it as a panacea but I think that bi-modal stimulation could help a lot of people.
- Apr 18, 2013
- 1,633
- Tinnitus Since
- 2003
- Cause of Tinnitus
- Flu, Noise-induced, Jaw trauma
At the expo they presented the results to date, Berthold Langguth gave the presentation.
They used THI and TFI to measure improvement. Data from 85 patients was presented, 95% CI, p>0.0001.
- Improvement rate (any improvement at all) on THI is 86%, on TFI is 88%
- The MCID (minimal clinically important difference) was set at 7 for THI and 13 for TFI
- Improvement above 7 points on THI by 66% of participants
- Improvement above 13 points on TFI by 46% of participants
I've asked them for a Q&A so hopefully we can do that this year with questions from the forum. We've done a few Q&A's before but we want to do more featuring people involved with interesting research and upcoming treatments.
I spent a couple of hours reading this thread from start to end, and that is my worry, too! Why would this second coming of MuteButton be any more successful? I'm fearful it's just good marketing, creating a hype. I'll remain dubious until internet has more positive experiences with the device.
- Apr 18, 2013
- 1,633
- Tinnitus Since
- 2003
- Cause of Tinnitus
- Flu, Noise-induced, Jaw trauma
This one has but there is also another larger trial that is (I believe) in progress. I'm careful about any of the conferences we go to when reporting data because if we happened to give away a key part of the trial then it could cause big problems to the reliability.
How are you limited? Did you sign a Confidentiality Agreement?
Anything they presented is now in the public domain.
The attached publications are from the Neuromod website. One looks to be the results of an open-label (not blinded) Phase I study and the other is a protocol for an exploratory study (is this the study that is ongoing?)
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Can't you ask your buddy Ross O'Neill? Wait... I think he won't be responding to you. Has he ever responded to you?
- Apr 18, 2013
- 1,633
- Tinnitus Since
- 2003
- Cause of Tinnitus
- Flu, Noise-induced, Jaw trauma
I haven't been told not to publish, it's based on past lessons learned and conversations I've had with researchers. One of the biggest problems researchers have faced is patients going online and unblinding trials or seeing information that changes the way they react or use a treatment, affecting the results of a study.
We do try and moderate these things. Having detailed information in the public domain during a trial can have detrimental effects on trial data and can also cause people to question the validity of the results as a consequence. It's something we try and do across the board rather than for any specific people, this really came to light during the AM-101 trials with conversations on Tinnitus Talk.
I think that the large trial is still running. The best thing for me to do is to ask the question, then I can come back with whatever is able to be reported.
Although we would all like to know everything about what's going on all the time @Steve is right. We will have to wait for the information to be published. Hopefully, it is sooner than later.
Great stuff Steve, thanks for giving us a description of the events.
Although I wish they would give dB instead of TFI/THI. I know they measured that but why not measure dB? I feel that it muddles the results a bit.
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