FDA approves first medical device to treat ADHD in children


toy "restlessness", popular with children, helps them to focus

The first medical device to treat attention deficit hyperactivity disorder in childhood, or ADHD, was approved on Friday by the US Food and Drug Administration. Designed for children ages 7 to 12 who currently do not take medication for the disorder, the device provides a low-level electrical pulse to the parts of the brain responsible for the symptoms of ADHD.

"This new device offers a safe and non-medicated option for the treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a novelty of its kind," said Carlos Peña, director of FDA's Division of Physical and Neurological Medicine Devices. Center for Devices and Radiological Health, said in a statement.

Called the External Monarch Trigeminal Nerve Stimulation System, eTNS, and marketed by NeuroSigma, the treatment is only available by prescription and must be monitored by a caregiver.

The pocket device is connected by wire to a small sticker placed on the child's forehead above the eyebrows. Designed to be used at home during sleep, it provides an electrical "tingling" stimulation to branches of the cranial nerve that provides sensations from the face to the brain.

A clinical trial of 62 children showed that eTNS increases activity in the brain regions that regulate attention, emotion, and behavior, all of the key components of ADHD.

Compared to a placebo, children who used the device had a statistically significant improvement in their ADHD symptoms, the FDA said, although it may take up to four weeks to improve.

The authors of the trial requested further research to examine whether the response to treatment will last over time and its potential impact on the development of the brain with prolonged use.

Stephen Hinshaw, a professor of psychology at the University of California, Berkeley, has led a large research study on ADHD since 1992. He said the evidence for the device is that "it seems safe, and the initial study is thoughtful and promising."

However, FDA approval was based on only a "single, small, short-term test – which did not compare eTNS to established treatments." The trial, he said, should be hopeful, but "much more research is needed to demonstrate ultimate effectiveness."

According to the NeuroSigma website, the device is not currently covered by insurance and can cost just over $ 1,000 for the starter kit.

No serious side has been reported during the clinical trial, the FDA said, but common side effects may include fatigue, drowsiness or difficulty sleeping, clenching of teeth, headache and increased appetite.

The device should not be used by children under 7 years of age, or by any child in an insulin pump, pacemaker, or implanted neurostimulator. It also should not be used near a cell phone, the FDA said, because the low levels of electromagnetic energy of the phone can disrupt therapy.

ADHD is among the most common childhood neurodevelopmental disorders. According to the US Centers for Disease Control and Prevention, children with ADHD may have difficulty paying attention, controlling impulsive behaviors, or being overly active. Doctors generally recommend some treatment options for children: medication, behavior modification, or both. Some commonly prescribed medications are amphetamine / dextroamphetamine, known as Adderall; methylphenidate, known as Concerta or Ritalin; and lisdexamphetamine, known as Vyvanse.

While not familiar with the specificities of the eTNS device, Atlanta pediatrician Dr. Jennifer Shu said she accepts non-medication ADHD treatment options.

"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 was previously approved for the treatment of epilepsy and depression in Europe and Canada. UCLA studies found that stimulation slowed the seizure activity by inhibiting superactive neurons in one part of the brain while stimulating blood flow in areas that control mood, attention, and executive function.

The device was also investigated as a possible treatment for traumatic brain injury in veterans.


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