ATLANTA (CNN) – The first medical device that treats childhood childhood deficiency, or ADHD, is OK on U.S. Friday. Food and Drug Administration. Assigned for children ages 7 to 12 who are not currently in the drug for disorder, the device delivers low-level electrical pulses on brain parts responsible for ADHD symptoms.
"This new device provides a safe, non-ADHD treatment option for pediatric patients by using mild nerve stimulation, the first of its kind," Carlos Peña, director of the Division of Neurological and Physical Medicine Devices at the FDA & # 39; s Center for Devices and Radiological Health, said in a
called the Monarch Trigeminal Nerve Stimulation System, eTNS, and sold by NeuroSigma, the treatment was available only through the prescription and must be monitored by a caregiver.
The device with an even size is connected by wire to a small adhesive patch placed on the forehead of the child above the eyebrows. Designed to be used at home while sleeping, it delivers "rotational" electrical stimulation in the branches of the cranial nerve that delivers sensations from the face to the brain.
A clinical trial of 62 children has shown that eTNS increases activity in the brain regions which interacts with attention, emotion and behavior, all major components of ADHD.
Compared to a placebo, children using the device have significant statistical improvements in their ADHD symptoms, the FDA said, although it may take up to four weeks to see improvements.
Clinical trials authors called further research to examine whether treatment response will last over time, and its potential impact on long-term brain development.
Stephen Hinshaw, a professor of psychology at the University of California, Berkeley, led a major ADHD research study since 1992. He said the device's pro was "it would appear to be safe, and the preliminary study was thoughtful and committed. "
However, the FDA signing off is based on a" single, small, short-term trial not comparable to eTNS in established treatment. "The trial, he said, depends on hope, but" more research is needed to show true spirit. "
According to the NeuroSigma website, the device is currently not covered by insurance and may cost just over $ 1,000 for the starter kit.
No clinical trials have been reported, but the FDA says, but the common side effects may include fatigue, sleepiness or sleep problems, clenching of teeth, headaches and appetite. .
do not wear children under the age of 7, or any child in an insulin pump, pacemaker or neurostimulator. Nor should it be used near a cell phone, the FDA said, because the low level of the electromagnetic energy of the phone may interrupt the therapy. ADHD is among the most common neurodevelopmental disorders of childhood. According to US Centers for Disease Control and Prevention, children with ADHD may have trouble paying attention, controlling impulsive behavior or being overly active. Doctors usually recommend some treatment options for children: medicine, behavior change or both. Some common prescription drugs are amphetamine / dextroamphetamine, known as Adderall; methylphenidate, known as Concerta or Ritalin; and lisdexamfetamine, known as Vyvanse.
While not familiar with the details of the eTNS device, the Atlanta physician doctor said. Jennifer Shu accepts ADHD treatment options without drugs.
"I encourage families to talk to their pediatrician or pediatric neurologist to see if this system can be a great choice for their children," Shu said.
The device was previously approved for the treatment of epilepsy and depression in Europe and Canada. UCLA studies found that stimulation reduced the seizure activity by prohibition of superactive neurons in a brain section, while stimulating blood flow in areas that control mood, attention and executive function.
The device is also being investigated as a possible treatment for traumatic brain injuries to veterans.
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