On Friday, the U.S. Food and Drug Administration (FDA) has approved the first medical device that helps treat attention deficit hyperactivity disorder (ADHD) in children.
The device is designated for children between the ages 7 and 12 who are not currently on any medication for ADHD. The function of the device is to deliver mild electrical impulse to certain parts of the brain responsible for causing ADHD symptoms.
Carlos Peña, the FDA’s director of the Division of Neurological and Physical Medicine Devices said, “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.”
NeuroSigma manufactures the Monarch external Trigeminal Nerve Stimulation System (eTNS), a medical device that is only available under a prescription and must be used with utmost caution by a caregiver.
eTNS is a pocket-sized device that is connected to a small adhesive patch by a wire. The patch is placed on the child’s forehead. It is ought to be used at home while sleeping. The device delivers a mild and tingling electrical impulse to the branches of the cranial nerve.
According to a clinical study performed on 62 children, eTNS increases activity in the areas of the brain that influence the key components of the ADHD symptoms, including attention, emotion, and behavior.
When compared with placebo, the device had significantly improved the symptoms of ADHD; however, it may take up to four weeks to notice improvement, said the FDA.
Professor of psychology at University of California Stephen Hinshaw, who led a large research study of ADHD since 1992, said, “It appears to be safe, and the initial study is thoughtful and promising.”
No serious side effects were reported during the clinical study. However, the FDA said that it might cause common side effects such as fatigue, trouble sleeping or sleepiness, teeth clenching, headache, or increased appetite.
According to the NeuroSigma, Monarch eTNS is not currently covered by health insurance and could cost more than $1,000 for the starter kit.
The FDA warned that eTNS should not be used by children below the age of seven, and children who are on an insulin pump, pacemaker, or implanted neurostimulator. The agency also warned that it should also not be used near a cell phone because the phone’s low-level electromagnetic energy may interrupt the therapy.
ADHD is one of the most common neurodevelopmental disorders in children. The Centers for Disease Control and Prevention (CDC) reports that children with ADHD might have difficulty paying attention, controlling impulsive behaviors, or be overly active.
Doctors often recommend a few treatment options that include medication, behavioral therapy, or both. The commonly prescribed ADHD medications include amphetamine/dextroamphetamine (Adderall), methylphenidate (Concerta or Ritalin), and lisdexamfetamine (Vyvanse).
In Europe and Canada, the device was approved for the treatment of depression and epilepsy. Clinical studies have found the mild electrical stimulation decrease the activity of seizure by inhibiting overactive neurons in one of the sections of the brain and stimulate blood flow in the areas that regulate mood, attention and cognitive function. The medical device is also getting investigated for the possible treatment of traumatic brain injury in the elderly.
