I didn't say there won't be any outcomes that are more dynamic. There will likely be a few lucky people that see complete remission. There will also be some people that experience no improvement. I suspect that most people will fall somewhere in between.
Three separate institutions are pursuing this approach so the technology clearly has potential. I happen to believe that the University of Minnesota and University of Michigan will be able to implement the technology with more robust results. That doesn't mean that the current device will be completely ineffective.
And in what century do you expect those to be released? I've been patient with Neuromod but at least they gave us a sign they were posturing to release, whereas those two are still stuck in the lab with no end in sight.
This question is interesting. It was not addressed by the Q&A.
Perhaps they have accounted for that. They might have also considered that the wires might tangle and cause the tongue tip to shock the wrong places, damage the wires over time, or just be too messy.
@linearb Having tinnitus for more than five years (one of the exclusion criteria) isn't a confounding condition.
In the TENT-A2 trial people with tinnitus up to 10 years were included. Source
That's better but would still exclude someone like me. They still should have done a TENT-A3 with no duration exclusion.
There are various theories about plasticity and things happening on a different timeline. My read on that exclusion criteria for this study is that they're a VC-backed for-profit company trying to maximize the efficiency they can demonstrate to make it easier to get to market.
I'd say I'm agnostic on the first issue, but agree that the second is a significant concern. Double blind RCTs are the gold standard; double blind RCTs are what UMich is doing, and this makes me a lot less suspicious of the UMich data despite smaller sample sizes. (I think UMich, so far, has shown somewhat less dramatic gains than what Neuromod is claiming? If so that all lines up neatly).
Yes. The lack of a true placebo cohort in Neuromod's trials concerns me very much as well. I wonder why UMich was able to devise a convincing placebo, but Neuromod did not. Perhaps Neuromod's level of electrical simulation is strong enough to be detected; I believe I remember reading that Shore's was below the tactile sensory level.
Yeah, UMich set the stimulation slightly below tactile, and in the sham period there was no electrical stimulation. But, what was communicated to participants (and to blinded clinicians) was that the sham period would either be no stimulation OR randomly timed stimulation. I believe it was communicated that way to make it even harder to unblind oneself.
At Minnesota, the electrical stimulation was set to threshold pain, and then backed down just a bit. It hurt a bit. The sham was using offsets that were imperceptibly different.
Please read the background research. Variations as much as 5ms is the difference between increasing or decreasing tinnitus.Or maybe the timings don't actually matter that much, and we can just go listen to tone generators and lick 9 V batteries and save ourselves 2500 EUR
I can't understand how Neuromod has managed to do this with Bluetooth headphones. Even if they account for the Bluetooth lag, the lag isn't the same all the time, it varies.
There is latency even with wired headphones just for everyone's information (although of course Bluetooth will be longer).
The generation of Bluetooth will also have some bearing on whether the lag is meaningful.
I am curious if anyone in Europe outside of Ireland has set up an appointment yet. Between here and Reddit the only people that have appointments are in Ireland. It makes me wonder if traveling is an option at all.
I have suggested this to Neuromod again recently, as has @Hazel in a follow-up message, along with other relevant ideas and suggestions.
Member
Founder