FDA OKs first medical device

As diagnosis rates of ADHD among children, a new medical device for the treatment of the disorder could be hitting the market.

The U.S. Food and Drug Administration announced ADHD. NeuroSigma Inc. based in Los Angeles.

Called the Monarch External Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children aged 7 to 12 who are not currently taking ADHD prescription medication.

The Monarch eTNS – an instrument the size of a cell phone – is designed for use with adult supervision. It connects via wire to a small patch placed on the forehead of the patient, generating a low-level electrical pulse to the brain.

ADHD news: Diagnosis rates for ADHD have risen 30% in 8 years

The connection provides a sensation on the skin, according to the FDA, and delivers a low-level electrical stimulation to the branches of the trigeminal nerve, which then sends therapeutic signals to the parts of the brain associated with ADHD. The FDA says that eTNS increases awareness of the importance of attention, emotion and behavior.

"This new device offers a safe, non-drug option for 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 statement.

Before Friday, the FDA has been granted only drug treatment for ADHD.

Clinical trials, according to the FDA, have suggested that the response time of the eTNS could be up to four weeks to become evident. A trial of 62 children with moderate to severe ADHD showed subjects using the eTNS had "statistically significant improvement" compared to ADHD children who were given a placebo device.

The average ADHD-RS score – used to measure ADHD – had decreased from 34.1 points to 23.4 points. That's compared to a decrease of 33.7 to 27.5 points among the placebo group.

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ADHD, a stress-relieving problem, difficulty controlling behavior and very high levels of activity. Symptoms of ADHD must be long-lasting, the person's functioning and cause to fall behind normal development for his or her age.

In the United States, the number of children diagnosed with ADHD is more than 30% over the past eight years with 2.4 million commercially insured American children diagnosed with the condition in 2014.

The FDA says the Monarch eTNS has several side effects – drowsiness, increase in appetite, sleeping disorder, teeth clenching, headache and fatigue – no serious adverse events associated with its use.

The device should not be used for children under 7 years old, the FDA says, or among patients with an active implantable peacemaker, active implantable neurostimulators or body-worn insulin pumps. Nor should the device be used in the presence of radio frequency energy or magnetic resonance imaging (MRI) or cell phones. The test was measured in an MRI machine and the phone's low levels of electromagnetic energy could disrupt the treatment.

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