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The Food and Drug Administration (FDA) on Friday approved the first medical device for treating attention deficit hyperactivity disorder in childhood, or ADHD.
The device, approved for children aged 7 to 12 years old who are not currently taking medication for ADHD, delivers a low-intensity electrical impulse to a patch placed on the forehead that interacts with the parts of the brain responsible for ADHD symptoms.
"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients through light nerve stimulation, a first of its kind," Carlos Peña, director of the FDA's Division of Physical Medicine and Neurological Apparatus Center for Appliances and Radiation Health, said in a statement.
"Today's action demonstrates our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their needs." special needs.
The device, called the Monarch External Trigeminal Nerve Stimulation System (eTNS), is marketed by NeuroSigma and is only available on prescription and must be monitored by a caregiver.
eTNS, designed to fit in a pocket, is connected by wire to a patch placed on the forehead during sleep and delivers a "swarming" electrical impulse to the branches of the trigeminal nerve.
"Although the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in brain regions recognized to play an important role in regulation of attention, emotions and behavior, "said the FDA.
The FDA also conducted a trial with 62 children with ADHD in which one group that used eTNS had a "significant improvement" in their symptoms as opposed to another group using a placebo.
Side effects of treatment include drowsiness, increased appetite, trouble sleeping, pinching teeth, headaches and fatigue. The device should not be placed near a phone or used by children with an insulin pump, pacemaker or implanted neurostimulator, the FDA has announced.
The FDA has not found any serious adverse events associated with eTNS.
According to the NeuroSigma website, the device is currently not covered by insurance and costs just over $ 1,000 for a starter kit.
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