FDA Approves First Medical Device To Treat ADHD In Children
(CNN) — The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK’d Friday by the US Food and Drug Administration. Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.
“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 Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
Called the Monarch external Trigeminal Nerve Stimulation System, eTNS,and marketed by NeuroSigma, the treatment is only available by prescription and must be monitored by a caregiver.
The pocket-sized device is connected by wire to a small adhesive patch placed on the child’s forehead above the eyebrows. Designed to be used at home while sleeping, it delivers a “tingling” electrical stimulation to branches of the cranial nerve that delivers sensations from the face to the brain.
A clinical trial of 62 children showed that the eTNS increases activity in the regions of the brain that regulate attention, emotion and behavior, all key components of ADHD.
Compared to a placebo, children using the device had statistically significant improvement in their ADHD symptoms, th...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN ADHD Source Type: news
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