Los Angeles, California-based medical device developer NeuroSigma has recieved De Novo clearance from the FDA for its Monarch eTNS System, which is the first non-drug treatment meant to address attention-deficit hyperactivity disorder approved in the U.S.
The device is indicated for patients between the ages of 7 and 12 who are not currently taking prescription ADHD medication. NeuroSigma previously received CE Mark approval in Europe for the device back in 2015.
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The acronym eTNS refers to external Trigeminal Nerve Stimulation. The cell phone-sized device delivers low-level electric stimulation to the trigeminal nerve through a patch placed on a patient’s forehead.
While the exact mechanism through which eTNS works is not yet known, the technique has been shown to increase activity in the brain regions that govern behaviors associated with ADHD.
The FDA’s regulatory decision was based on a controlled study in which 62 pediatric patients with moderate to severe ADHD used Monarch or a placebo device over a period of four weeks.
Children in the treatment group were found to have a “statistically significant improvement” in their ADHD symptoms compared to the control group, when measured on a clinician-administered ADHD Rating Scale.The device is not currently covered by insurance and retails for around $900.
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“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, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
“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.”
Common side effects ranged from drowsiness to headache and fatigue. No serious adverse effects were found to be associated with the device.
NeuroSigma is attempting to use eTNS techniques on a variety of different behvioral health conditions including depression and epilepsy.
The company isn’t the only organization looking at alternatives to traditional drug-based therapies for ADHD.
Boston-based Akili Interactive Labs is developing a video game-based digital therapeutic for the condition, which is currently undergoing regulatory review by the FDA.
Photo: Thinglass, Getty Images
