Privately-held NeuroSigma has received FDA approval to market its Monarch external Trigeminal Nerve Stimulation (eTNS) System to attention deficit hyperactivity disorder (ADHD) patients.
Indicated in patients from seven-to-12 years of age who are not currently taking prescription ADHD medication, the Monarch eTNS System delivers low-level electrical stimulation to the trigeminal nerve, which then stimulates parts of the brain thought to be involved in ADHD.
“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, director of the FDA’s Division of Neurological and Physical Medicine Devices, said in a statement.
The FDA’s approval was based on a clinical trial that compared eTNS monotherapy to a placebo device in 62 children with moderate-to-severe ADHD. After the eTNS System or a placebo device was used each night at home for four weeks, results demonstrated that subjects using the eTNS device had a statistically significant improvement in ADHD symptoms, compared with the placebo group.
