Lenire — Bimodal Stimulation Treatment by Neuromod
- Thread starter Tinnitus Talk
- Start date
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I think data should be analysed on the following aspects:
1. Tinnitus cause
I assume the question has been asked of "how did your tinnitus start?", or perhaps "what do you think is the cause of your tinnitus?". Focus on those cases where the cause is fairly certain, with people who know for sure what event triggered their tinnitus, and compare the effects between these subgroups. There will always be some uncertainty (not everyone is properly diagnosed), but statistics could at least give a lead on what types are affected by the treatment.
2. Tinnitus symptoms
Stop considering tinnitus as one symptom: check the data on the type (and multitude) of sounds that people hear, and see if there are similar effects with the treatment for people with similar sounds. Of course, sound descriptions can be a bit vague, but again the statistics could give a lead when differences between numbers are high enough.
I assume the researchers understand the concepts of cause, effect and variable exclusion sufficiently to come up with analyses like these, but fairly, I lost a bit of faith in the medical community after seeing how my audiologist tried (and failed) to diagnose me... but since researchers usually have a different mindset, I'm not without hope yet.
Doesn't Neuromod say that temporary worsenings are normal and to be expected during the initial consult?
Yes but that's not what he's talking about. He made it pretty clear a few weeks ago that he actually thinks it worsening tinnitus instead of improving it is just as likely.
But in that case, saying that it got worse because it temporarily worsened the tinnitus then made it better is bad wording.
That's what they say on the one hand, while refusing to disclose actual statistics with the other. I would not decide on whether to take a risk purely based on their word.
The way he brushed past that in the first interview did not inspire a lot of confidence.
Remember when people were wondering whether they force patients to sign NDAs? Neuromod is foolish if they think they can hold back or spin data at odds with factual reality because word of mouth simply takes its place. The results are the results and the truth comes out regardless.
- Jun 13, 2019
- 1,108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Started with a cold, possibly worsened by medication/noise
@threefirefour, may I ask you your help? Sorry if you explained this before. I have to make a decision shortly on whether to keep my appointment or cancel it.
I'm trying to assess the pros and cons.
Your anecdotal figures point to a 70% improvement in population, with this being a sizeable/noticeable improvement and not placebo. Is that right?
Is it correct that very severe cases like me are the least likely to get benefit? This is what I gathered from the leaked scatterplot.
Do you have any figures also for worsening?
Thanks.
4-5 weeks, fairly late into the first 6-week round. All I got during the first few days was spikes lol.
If the tinnitus is pretty severe Lenire might not help that much. On the other hand you haven't had it that long (10/2018). That could improve your chances, I guess.
I think the least benefit will get the people that have severe tinnitus and have had it for a long time (like me). There's a 95% chance I will cancel my late April appointment, but mostly because of the possible worsening, not the money/placebo thing.
- Oct 17, 2017
- 641
- Tinnitus Since
- 2005
- Cause of Tinnitus
- unknown - possibly hereditary
- Jun 13, 2019
- 1,108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Started with a cold, possibly worsened by medication/noise
Thank you, Ann. Severe cases seem to have gone down from 90 to 70 or 80 at final. I guess that is something but only two datapoints. What are the first plots, where there have been a lot of worsening?
@threefirefour's numbers aren't accurate but he just ignores rebuttals and blindly doubles down. People should not take his input on Lenire seriously.
- Jun 13, 2019
- 1,108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Started with a cold, possibly worsened by medication/noise
I was also looking at the last scatter plot that seems to be not too bad, although the earlier ones are worrying in terms of worsening.
We're now only about a month away from Tinnitus Talk issuing its formal report. Going round the room yet again with the optimists arguing with pessimists doesn't make much sense. It's not like we haven't heard all these arguments already, so it's going nowhere. I'm sure despite what that report says it won't stop the bickering but it should at least eliminate the added noise of people trying to offer up their conclusions solely from gleaning things out of the User Experiences thread.
- Jul 8, 2019
- 1,148
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
I totally understand where you're coming from. I'm in exactly the same boat and am really only concerned with:
- Worsening
- Time since tinnitus onset
Time since tinnitus onset has been a real barrier to this kind of treatment for me. This isn't because I don't believe in bi-modal stimulation, quite the contrary, it's because both Neuromod and Susan Shore's team restricted the time since tinnitus onset in their own trials.
Neuromod were the more flexible with their test subjects. In their original trial I understand they limited time since tinnitus onset to <5 years. In their second trial, which I believe was more geared toward formulating the stimulation timings, my understanding is that they expanded the time since tinnitus onset to <10 years.
Unfortunately, the same level of flexibility did not seem to apply to Susan Shore's subjects. If my understanding is correct, the current trial protocol limits time since tinnitus onset to >6 months but preferably <1 year. I was absolutely staggered when I found this out - so much so that I corresponded with Susan Shore about it. I don't feel it's appropriate to copy and paste emails here, suffice to say I haven't been able to find any information in the public domain where she says time since onset doesn't seem to matter. The same is not true, however, for Ross O'Neill.
In the last interview Ross O'Neill gave Tinnitus Talk when asked the question, Does Tinnitus Duration Matter? he stated the following:
"We have not seen anything yet that suggests that duration is important. In TENT-A1 up we looked up to 5 years and in TENT-A2 we extended that. Duration hasn't emerged as important but we will continue to use all of the post-market clinical follow-up data that we are obliged to collect from a regulatory perspective, to see if duration and other variables are important. We studied 500 plus patients in the Clinical Trial but, hopefully, we'll get the opportunity to study thousands, if not tens of thousands of patients, in the post-market clinical phase and in that process we'll probably actually learn more in the post-market phase than we will in the Clinical Trial phase. But, as I said it's the first step in a journey of continuous improvement towards more targeted, personalised treatments."
My response to this is really straightforward: if there is currently nothing to suggest that duration is important why place the restriction on time since onset in the trials? This is such a vexing point! Even more so where Susan Shore's criteria is concerned because her device is being held up as the lantern to a flailing Lenire.
The UMich device isn't commercialised yet so I can give Dr. Shore a break. I'm struggling with Neuromod, however. Even if they were way more lenient in their trials with time since onset the data for long term cases doesn't exist because they didn't test for it. And that leaves longer term sufferers with a stark choice - do we go for it, or do we not? Either way, I guess we have to accept that we are basically the "post-market phase" of a "continuous improvement towards more targeted, personalised treatments". Woo-Hoo.
- Jul 8, 2019
- 1,148
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
I'm not a researcher, but from a programmers perspective, this makes perfect sense. Having more variables around generates more noise (pun unintended) in the test results. With a complicated condition as tinnitus, you want as few differences as possible among the test subjects, especially when the amount of subjects is limited.
I completely understand your frustration, but this way of working should be the most reliable.
This is coming from the dude who says only 10% had a statistically significant reduction lmao I ain't taking flak from someone who doesn't understand statistics.
I don't ignore rebuttles you do. Everytime you questioned my stats I replied. Everytime I question yours you rarely do. This is some advanced projection.
From what I understand, it seems that the most severe cases aren't necessarily less likely to receive true improvement; but they are less likely to notice an improvement
And yes the 70% improvement in general population is real improvement not just placebo. It's just mild
We had a member, @kelpiemsp, who was on the Minnesota trial (not mentioned as often here) who had tinnitus for a very long time and was helped with it quite dramatically. That is really what got me thinking neuromodulation could work for those who had it for a long time.
During my eight weeks of using Lenire, I had two bright spots. The first week, I had an awful flu, and my tinnitus was very low. Was this due to the device, or the flu? Probably a combination of both, because I have never had tinnitus that low. It elevated again, and then after a bad earwax impaction which caused me a lot of stress, my tinnitus went to severe levels.
Two weeks after severe levels, I had brief relief when I got a migraine, which always tends to bring my tinnitus down. Again Neuromod was unable to explain why Lenire worked particularly well when I experienced the flu or migraine. Regardless, these improvements were short-lived and had confounding factors.
What baffles me about the whole situation is how little Neuromod seems to know. I want more information, like why certain things happen, why doesn't it work for some people, SOMETHING. They're very friendly and responsive, but when the responses don't hold much value what's the point.
Given the coronavirus, I am not planning on flying back (I live in the US) to Ireland anytime soon. I asked if there was a way to update remotely but they said this is not possible.
My tinnitus fluctuates from moderate-bad-severe. Before I got the device I was beginning to get more moderate days. Now it's mostly bad or severe, with the few highlights I mentioned.
Two weeks after severe levels, I had brief relief when I got a migraine, which always tends to bring my tinnitus down. Again Neuromod was unable to explain why Lenire worked particularly well when I experienced the flu or migraine. Regardless, these improvements were short-lived and had confounding factors.
What baffles me about the whole situation is how little Neuromod seems to know. I want more information, like why certain things happen, why doesn't it work for some people, SOMETHING. They're very friendly and responsive, but when the responses don't hold much value what's the point.
Given the coronavirus, I am not planning on flying back (I live in the US) to Ireland anytime soon. I asked if there was a way to update remotely but they said this is not possible.
My tinnitus fluctuates from moderate-bad-severe. Before I got the device I was beginning to get more moderate days. Now it's mostly bad or severe, with the few highlights I mentioned.
I think it's the future of tinnitus treatment. I hope we get a lot even more effective treatments like this. I personally think we're going to need neuromodulation treatments that target multiple areas of the brain.
Something to consider when looking at the scatter plots is the term at the top of each plot: "Compliant Subjects Only"
This means that only subjects who completed the treatment for the full 1 hour per day for the 12 weeks duration are shown on the scatter plots. So it is excluding the data for anyone who stopped treatment anything short of 12 weeks because of worsenings. Probably why the scatter plots aren't really showing any worsenings if subjects stopped using the device prior to full treatment.
- Jul 8, 2019
- 1,148
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
Cheers for this. I went back and read his posts - tinnitus from birth, and Minnesota/Hubert Lim cured him.
I found this quote of kelpiemsp's intriguing:
kelpiemsp said:
In fairness to Neuromod (yes, I do try to be fair) we really don't know the details behind the non-compliance. There definitely is a regimen to it and not everyone has the required discipline. So some of them probably just didn't stick to it well enough to classify them as "compliant". I don't think all of the non-compliant ones are worsenings, although it could very well be some.
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