The FDA has approved first non-drug medical device designed to treat attention deficient hyperactivity disorder (ADHD) in children. The device helps the brain to regulate attention and emotion in these children.
It was on April 19th that the life sciences company NeuroSigma received its FDA approval to market the device. The device has not yet been accepted by insurance and a starter kit may go for about $900, reported the company.
“This new device offers a safe, non-drug option for treatment of ADHD in paediatric 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, said in a press statement.
The device which is known as the Monarch external Trigeminal Nerve Stimulation (eTNS) System is designed to deliver low-level electrical pulses to parts of the brain associated with ADHD. These pulses increase activity in areas of the brain that regulate emotion, attention, and behavior, according to the FDA.
“It emits a low-level electrical pulse that essentially stimulates a cranial nerve called the trigeminal nerve and the idea is that nerve then sends signals into the brain particularly to the areas that are important for attention, for functioning and behaviour,” Dr. Tara Narula cardiologist, Assistant Professor of Cardiovascular Medicine for Hofstra University NSLIJ School of Medicine and Associate Director of the Cardiac Care Unit at Lenox Hill Hospital/NSLIJ in Manhattan.
The device is formulated to be used by children between the ages of 7 and 12 who does not take prescription of ADHD medication. The eTNS system measures about the size of a cell phone. It connects via a small wire to an adhesive patch placed on the child’s forehead. FDA states that the device can be used at home, during sleep, and under the supervision of a caregiver.
Though eTNS is a breakthrough therapy for ADHD, it may not always be considered as a first-line treatment for most.
The FDA advises that people who use an implantable pacemaker, neurostimulator, or body-worn device such as an insulin pump should not use eTNS. Furthermore, the device should not be used near radio frequency energy such as magnetic resonance imaging (MRIs) and cell phones as researchers think it may disrupt the therapy.