NEW YORK (FOX 5 NY) - The Food and Drug Administration has approved a new treatment for Attention Deficit Hyperactivity Disorder in children ages 7-12 who are not currently taking prescription ADHD medication.
A cell-phone size device sends low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD, according to the FDA.
The FDA granted marketing authorization of the prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System to NeuroSigma.
It could take up to four weeks before improvements are noticed.
Children with ADHD often have difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity.
“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.”
The most common side effects observed with eTNS use were drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.
The company says the device should not be used in children under seven years of age.