The Monarch external Trigeminal Nerve Stimulation (eTNS) System, which is the size of a cell phone, emits a low-level electrical pulse through a wire to a small patch attached to a patient’s forehead, stimulating branches of the trigeminal nerve and sending therapeutic signals to parts of the brain believed to be associated with ADHD.
In a clinical trial comparing eTNS to a placebo device, subjects who used eTNS every night for four weeks experienced statistically significant improvement in their ADHD symptoms, according to the FDA.
The prescription-only eTNS system, the first non-drug ADHD treatment approved by the FDA, can be used by children between the ages of 7 and 12 who are not currently on medication for ADHD. The device is designed for home use, to be employed and monitored by a caregiver while the patient sleeps.
The FDA’s approval allows NeuroSigma, a Los Angeles-based biotech company focused on developing therapies involving Trigeminal Nerve Stimulation (TNS) technology, to market the device in the U.S.
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