The Clinical Trial used for FDA Approval
The eTNS Monarch device was approved based only on a 4 week clinical trial including merely 62 subjects, of which only 32 received the active device. It was completed with a follow-up on week 5. This is an astonishingly small and short-term study for FDA approval compared to research requirements most drugs are subjected to by the FDA. This alone is sufficient reason to avoid this device.
The Clinical Trial: Trigeminal Nerve Stimulation for ADHD (TNS for ADHD)
Two clinical trials extended from that initial 4-week trial, drawing on the same 62 subjects. The first extension trial was of subjects who were in the placebo group offered to try the Monarch device for 4 weeks (so it was not a proper blinded trial). The second extension trial was a 12-month trial offered to subjects who were not in the placebo group and who reported improvement in the initial 4-week trial. Of note, 83% of the subjects dropped out of the 12-month trial before it ended (see Results). The 12-month extension trial started with a mere 18 subjects and ended with only 3 enduring the full 12 months of brain zapping. So the only long-term study of the Monarch device was a complete bust and no statistical analyses were reported.
The company’s published a paper (below) only reveals the initial 4-week trial, ignoring their failed 12-month extension trial, which is only discoverable by way of the National Library of Medicine’s clinical-trials database linked-to here.
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