The US Food and Drug Administration on Friday approved the first medical device designed to treat attention deficit hyperactivity disorder (ADHD) in children (ADHD). Aimed at children aged 7 to 12 who are not taking medication for the treatment of the disease, the device delivers a low-intensity electrical impulse to the parts of the brain responsible for the symptoms of ADHD.
"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients through light nerve stimulation, a first of its kind," Carlos Peña, director of the FDA's Division of Physical Medicine and Neurological Apparatus Center for Appliances and Radiation Health, said in a statement.
Called eTNS, the external trigeminal nerve stimulation system Monarch, marketed by NeuroSigma, treatment is only available on prescription and should be monitored by a caregiver.
The pocket-sized device is connected by wire to a small adhesive patch placed on the child's forehead above the eyebrows. Designed to be used at home during sleep, it delivers to the branches of the cranial nerve an electrical stimulation that teems with sensations that provide sensations of the face to the brain.
A clinical trial of 62 children showed that the eTNS system increased activity in areas of the brain that regulate attention, emotions, and behavior, all key components of ADHD.
Compared to a placebo, children using this device showed a statistically significant improvement in their ADHD symptoms, the FDA said, although it may take up to four weeks to see an improvement.
The authors of the clinical trial asked for further research to determine if the response to treatment would last in time and its potential impact on brain development in the event of prolonged use.
Stephen Hinshaw, a professor of psychology at the University of California at Berkeley, has led an extensive study on ADHD since 1992. He has demonstrated that the device proves that it "seems to be safe and that the" initial study is thoughtful and promising. "
However, the FDA's approval was based on the "only small, short-term trial – which did not compare eTNS to established treatments," he added. research is needed to demonstrate the ultimate effectiveness. "
According to the NeuroSigma website, the device is currently not covered by insurance and could cost just over $ 1,000 for the starter kit.
The FDA has stated that no serious adverse events have been reported during the clinical trial, but that common side effects could be fatigue, drowsiness or sleep disturbances, pinching teeth, headaches and an increase in appetite.
The device should not be worn by children under 7 years of age or children receiving an insulin pump, pacemaker or implanted neurostimulator. It should also not be used near a cell phone, the FDA said, as low levels of electromagnetic energy from the phone could interrupt treatment.
ADHD is one of the most common neurodevelopmental disorders of childhood. According to the US Centers for Disease Control and Prevention, children with ADHD may have difficulty paying attention, controlling their impulsive behavior, or being too active. Doctors usually recommend some treatment options for children: medications, behavior modification, or both. Some commonly prescribed drugs are amphetamine / dextroamphetamine, known as Adderall; methylphenidate, known as Concerta or Ritalin; and lisdexamfetamine, known as Vyvanse.
Although she does not know the specifics of the eTNS device, Dr. Jennifer Shu, pediatrician in Atlanta, welcomes treatment options for ADHD that do not include drug treatment.
"I would encourage families to talk to their pediatrician or pediatric neurologist to see if this system could be a good option for their child," Shu said.
The device had already been approved for the treatment of epilepsy and depression in Europe and Canada. Studies conducted at UCLA have shown that stimulation decreases epileptic activity by inhibiting hyperactive neurons in one part of the brain, while stimulating blood flow in areas that control the mood, the attention and executive functions.
The device has also been studied as a possible treatment for traumatic brain injury in veterans.