For the first time, children in the United States will have a non-drug option for treating attention deficit hyperactivity disorder (ADHD). The FDA just cleared the Monarch external Trigeminal Nerve Stimulation (eTNS) System from NeuroSigma, a Los Angeles, California company, to treat ADHD in kids between 7 and 12 years old. The system has already been used to treat posttraumatic stress disorder (PTSD), epilepsy, and depression.
The Monarch delivers low-energy electrical current through an electronic patch attached to the forehead. It creates a tingling sensation, but otherwise there doesn’t seem to be any pain or discomfort that kids should feel during therapy. The therapy is by prescription only, and parents or other caregivers are expected to assist kids during treatment sessions.
“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,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects 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 unique needs.”
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Though it’s not yet clear how trigeminal nerve stimulation actually works, it has been shown that it does increase brain activity in regions responsible for mental attention, behavior, and emotional response.