Thanks, Michael. This does provide a little more of the study design and one statistically significant outcome re: PTSD, which supports the FDA's decision. But it doesn't answer most of my questions (percent who improved in each group, side effects, study dropouts, etc.). And more importantly, who is scouring the internet for a document of abstracts from a 2025 sleep conference to try to find a tiny tidbit of information about a PTSD device buried 37 pages deep? If a patient or doctor are going to use this device, shouldn't the data on safety and efficacy be readily accessible—say from the FDA, the company, or the news reports on the device coming out now, in mid-2026?
The FDA has been absolutely stripped to barebones over the years and we are seeing the effects of that now. I do wonder how much is being run through AI tools to help speed up the process and how much of this is reviewers not understanding how something works. Sometimes, part of the deal is teaching the FDA reviewers how something works so they can evaluate it. In this case, the lack of data release is telling. We can't see "compared to what" or who ran the trial and collected the data ( and so many trials are being paid for by the company seeking approval).
This device sounds like an at-home version of Transcranial Magnetic Stimulation, which seems to be problematic even when done by professionals in a clinic setting. There is an entire Facebook group, Victims of TMS, whose more than 5,000 members tell of horrific, longterm harm from treatment with this type of electrical device. Combine this with the facts laid out in Peter's essay --we know very little about the studies surrounding the Modius Spero, and its approval doesn't mean it works-- and we're looking at a risky proposition for people who are already traumatized.
The media coverage doesn't surprise me, though. Too often science/health reporting has a "gee whiz!" quality, framing every new thing as a potential breakthrough and evincing little curiosity or scrutiny.
The forces behind psychiatry will not give up easily, if they ever do. They are determined to keep psychiatry as a destructive force on Earth, while professing help. Rotten to the core.
Years ago, I had EMDR using the electrodes held in your hands. The therapy was done by an expert therapist, in a controlled, safe environment. We processed memories over several weeks, one at a time. It worked great! But the trauma I processed was intense. I cannot imagine doing this by myself. This device could cause serious brain damage and could cause the client to self-harm or harm others.
Actually i did find this, page 37
https://www.sleepmeeting.org/wp-content/uploads/2025/05/sleep-2025-late-breaking-abstracts.pdf?utm_source=chatgpt.com
Thanks, Michael. This does provide a little more of the study design and one statistically significant outcome re: PTSD, which supports the FDA's decision. But it doesn't answer most of my questions (percent who improved in each group, side effects, study dropouts, etc.). And more importantly, who is scouring the internet for a document of abstracts from a 2025 sleep conference to try to find a tiny tidbit of information about a PTSD device buried 37 pages deep? If a patient or doctor are going to use this device, shouldn't the data on safety and efficacy be readily accessible—say from the FDA, the company, or the news reports on the device coming out now, in mid-2026?
yeah I agree, just wanted to share it so you're bullet-proof
OMG
The FDA has been absolutely stripped to barebones over the years and we are seeing the effects of that now. I do wonder how much is being run through AI tools to help speed up the process and how much of this is reviewers not understanding how something works. Sometimes, part of the deal is teaching the FDA reviewers how something works so they can evaluate it. In this case, the lack of data release is telling. We can't see "compared to what" or who ran the trial and collected the data ( and so many trials are being paid for by the company seeking approval).
Our complaints about these people are seen by them as little more than dogs barking outside their house.
We need to find honest professionals who are getting results to just take over this field.
The criminals, though, will never give up unless we find a way to make them sane. They are the real mental health problem on this planet.
Actually, i did find this. Page 38 https://www.sleepmeeting.org/wp-content/uploads/2025/05/sleep-2025-late-breaking-abstracts.pdf?utm_source=chatgpt.com
This device sounds like an at-home version of Transcranial Magnetic Stimulation, which seems to be problematic even when done by professionals in a clinic setting. There is an entire Facebook group, Victims of TMS, whose more than 5,000 members tell of horrific, longterm harm from treatment with this type of electrical device. Combine this with the facts laid out in Peter's essay --we know very little about the studies surrounding the Modius Spero, and its approval doesn't mean it works-- and we're looking at a risky proposition for people who are already traumatized.
The media coverage doesn't surprise me, though. Too often science/health reporting has a "gee whiz!" quality, framing every new thing as a potential breakthrough and evincing little curiosity or scrutiny.
Psychiatric betrayal
Psychiatry don't know what to do
If compared to ther invention, i rather use my stereo headphone and listen to music i prefer
Will psychiatry ever come to sense?
The forces behind psychiatry will not give up easily, if they ever do. They are determined to keep psychiatry as a destructive force on Earth, while professing help. Rotten to the core.
Years ago, I had EMDR using the electrodes held in your hands. The therapy was done by an expert therapist, in a controlled, safe environment. We processed memories over several weeks, one at a time. It worked great! But the trauma I processed was intense. I cannot imagine doing this by myself. This device could cause serious brain damage and could cause the client to self-harm or harm others.
Yep. As a psychiatrist : what the fuck is this.
Thanks Peter, I'll pass it to the Veteran groups I know.