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.
See the Amazing New Video about the Horror of
Putting Electrodes on our Children’s Heads
Great podcast interview of Dr. Breggin by Ken McCarthy. Ken also provides
extraordinary background data with citations on the enormous powers behind electrical assault on children
including military-industrial complex connections and promotion by the FDA.
Contact SPAC! project @ SPACVictory@outlook.com