"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.
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.
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.
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.
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Michelle Watson contributed to this report.