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“This new device offers a safe, nondrug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the FDA’s Division of Neurological and Physical Medicine Devices, in the agency press release. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe, and effective medical devices that meet their unique needs.”
The Monarch eTNS System delivers low-level electrical pulses to a child’s trigeminal nerve while the child sleeps via wires and a small patch adhered to the child’s forehead. The exact mechanism of eTNS is not yet known, but neuroimaging studies have shown that the trigeminal nerve connects to brain regions that are important in regulating attention, emotion, and behavior.
The efficacy of the Monarch system was shown in a recently published clinical trial of 62 children with ADHD. The participants randomly received either eTNS or sham nerve stimulation nightly for four weeks. At the study’s completion, the children using the eTNS device had a statistically significant improvement in their ADHD symptoms compared with the sham group, as measured with the clinician-administered ADHD Rating Scale. The device was well tolerated; the most common side effects observed with eTNS were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue.
The FDA cautions that the Monarch eTNS System should not be used in children with active implantable pacemakers, active implantable neurostimulators, or body-worn devices such as insulin pumps. The eTNS System also should not be used in the presence of cellular phones, since the low levels of electromagnetic energy emitted by the phone may interrupt the therapy.
The Monarch eTNS System will be marketed by NeuroSigma. To read more about the Monarch eTNS clinical study, see the Psychiatric News article, “NoninvasiveElectrical Stimulation Shown Effective for ADHD.”
(image: iStock/evgenyatamanenko)
