The first medical device to treat childhood attention deficit hyperactivity disorder (ADHD) was approved by the US Food and Drug Administration on Friday. The device is intended for children from 7 to 12 years of age who are currently taking no medication for the condition and sends a low level of electrical impulse to the hemispheres responsible for ADHD symptoms.
"This new device provides a safe, drug option for the treatment of ADHD in pediatric patients through the application of mild nerve stimulation, a premiere of its kind," said Carlos Peña, director of the Department of Neurological and Physical Medical Devices at the Center for Devices and radiological health of the FDA statement.
The "Monarch" external trigeminal nerve stimulation system (eTNS) marketed by NeuroSigma is available only by prescription and must be monitored by a caregiver.
The device in pocket size is connected with a wire small adhesive plaster on the forehead of the child over the eyebrows. Designed for home sleep, it provides a tingling electrical stimulation to the cranial nerve branches that trigger sensations from the face to the brain.
A clinical study of 62 children showed that eTNS enhances brain activity. Regions of the brain that regulate attention, emotions and behavior are all key components of ADHD.
Compared with a placebo, children who use the device had a statistically significant improvement in their ADHD symptoms, the FDA said, although they may need up to four weeks to see an improvement.
Clinical trial authors called for additional research to investigate whether treatment response will continue over time and what potential impact it may have on brain development over extended periods of use.
Stephen Hinshaw, Professor of Psychology At the University of California, Berkeley, since 1992 has conducted a large study on ADHD. He said the proof that the device "seems safe, and the initial study is thought" l and promising. "
The FDA's approval, however, was based only on the single, small, short-term study in which eTNS was not compared to established therapies. Hope, but "much more research is needed to demonstrate the ultimate in effectiveness."
According to the NeuroSigma website, the device is currently not covered by insurance and could be used for starter Kit cost just over $ 1,000.
No Serious Problem Side effects have been reported during the clinical trial, the FDA said, but common side effects could include fatigue, drowsiness or sleep disturbances, teeth grinding, headache and an increase in appetite.
The device should not be worn by children under the age of 7 or a child with an insulin pump, pacemaker or implanted neurostimulator. It should also not be used near a cell phone, the FDA said, because the phone's low electromagnetic energy can disrupt the therapy.
ADHD is one of the most common neurodevelopmental disorders in childhood. 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. Atlanta-based Jennifer Shu, unaware of the peculiarities of the eTNS device, said she welcomed ADHD treatment options that do not require medication.
"I would encourage families to speak Shu.
The device was previously approved for the treatment of epilepsy and depression in Europe and Canada. Studies at UCLA found that stimulation reduced seizure activity by inhibiting overactive neurons in one part of the brain and stimulating blood flow in areas that control mood, attention, and executive function.
The device has also been studied as a potential treatment for traumatic brain injury in veterans.