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ADHD treatment: FDA is the first medical device to treat childhood ADHD



"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients by the use of mild nerve stimulation, a premiere of this kind," Carlos Peña, director of the Department of Neurological and Physical Medical Devices in the FDA Center for equipment and radiological health, said in a statement.

Monarch's external trigeminal stimulation system (eTNS), marketed by NeuroSigma, is only available by prescription and must be monitored by a caregiver. 19659002] The bag-sized device is connected to a wire with a small adhesive patch that is placed over the eyebrows on the child's forehead. Developed for sleeping at home, delivering "tingling" electrical stimulation to cranial nerve branches that trigger sensations from the face to the brain.

A clinical study of 62 children showed that eTNS enhances brain activity in brain regions that regulate attention, emotion and behavior, 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 it could take up to four weeks to see improvement.

Authors of the clinical trial requested additional research to investigate whether the response to treatment will continue over time and what effect this may have on brain development over extended periods of use.

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

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.

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The device should not be used by children under 7 years or by Children are worn with insulin pumps, pacemakers or pulses lanted 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 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.

Although the connoisseur of the eTNS device is unfamiliar, Pediatrician Dr. Jennifer Shu from Atlanta says she welcomes ADHD treatment options that do not require medication.

Families who should talk to their pediatrician or neurologist to see if this system could be a good option for their child, "said Shu.

The device was previously used to treat epilepsy and depression in Europe and Africa Studies at UCLA found that stimulation reduced seizure activity by inhibiting overactive neurons in one part of the brain and stimulating blood flow in those areas that control mood, attention, and executive function.

possible treatment for investigating traumatic brain injury in veterans.

Michelle Watson contributed to this report.


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