"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a premiere of its kind," said Carlos Peña, director of the Department of Neurological and Physical Medical Devices of the FDA Center for Devices and Radiological health, said in a statement.
The monarch-external trigeminal nerve stimulation system (eTNS) marketed by NeuroSigma is offered by prescription only and must be monitored by nursing staff.
The bag-sized device is connected by a wire with a small adhesive patch, which is on the child's forehead above the eyebrows. Designed for the home while you sleep, it provides a "tingling" electrical stimulation to the cranial nerve branches that directs sensations from the face to the brain.
Children who use the device had a statistically significant improvement in their ADHD symptoms compared to a placebo, the FDA said, although it could take up to four weeks to see an improvement.
The authors of the clinical study called for additional research to investigate whether the response to treatment continues over time and how this affects prolonged brain development.
No serious side effects were reported during the clinical trial, the FDA said. However, common side effects may include tiredness, drowsiness or sleep disturbances, teeth grinding, headaches and an increase in appetite.
ADHD is one of the most common childhood neurodevelopmental disorders. According to the US Centers for Disease Control and Prevention, children with ADHD may have difficulty being alert, controlling impulsive behavior, or being overly active. Doctors usually recommend some treatment options for children: medication, behavioral modification, or both. Some commonly prescribed medications are amphetamine / dextroamphetamine, known as Adderall; Methylphenidate, known as Concerta or Ritalin; and lisdexamfetamine, known as Vyvanse.
The Pediatrician Dr. While not familiar with the peculiarities of the eTNS device, Jennifer Shu from Atlanta said she welcomed ADHD treatment options that do not require medication.
"I would encourage families to talk to their pediatrician or neurologist to see if this system is a good option for their child," Shu said.
The device has also been studied as a potential treatment for traumatic brain injury in veterans.
Michelle Watson contributed to this report.