As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of the disorder could soon be hitting the market.
The U.S. Food and Drug Administration announced Friday that it has permitted marketing for the first medical device to treat ADHD. The authorization has been granted to the life sciences company NeuroSigma Inc. based in Los Angeles.
Called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 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 at home 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.
The connection provides a tingling 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 the eTNS increases activity in the brain regions that are known to be important in regulations attention, emotion and behavior.
"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 statement.
Before Friday, the FDA had 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.
After four weeks into the study, 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.
ADHD, a common and growing disorder that begins in childhood, includes difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. Symptoms of ADHD must be long-lasting, impair the person's functioning and cause the person to fall behind normal development for his or her age.
In the United States, the number of children diagnosed with ADHD is up 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, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue — but 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 devices such as insulin pumps. Nor should the device be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI) or cell phones. The test has not been measured in an MRI machine and the phone's low levels of electromagnetic energy could disrupt the treatment.
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