A recent press release from the U.S. Food and Drug Administration (FDA) certainly caught our attention! In April, FDA permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The device, known as the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is for prescription use only and intended to be used in patients ages 7 to12 years old who are not currently taking prescription ADHD medication. The device was developed by NeuroSigma, and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.
ADHD is a common disorder that often begins in childhood, with symptoms including inattentiveness, impulsiveness, and very high levels of activity. A diagnosis of ADHD requires a comprehensive evaluation by a health care professional, and for a person to receive an ADHD diagnosis the symptoms must impair the their functioning and cause them to fall behind normal development for his or her age.
The Monarch eTNS System is intended to be used at home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows. The stimulation should feel like a tingling sensation on the skin, and is administered by the caregiver when the child is asleep. The device is purported to stimulate the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.
“This new device offers a safe, non-drug 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 Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “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 FDA reviewed the Monarch eTNS System via the de novo premarket review pathway (previously blogged about HERE and HERE), a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. The main mitigation measures included biocompatibility evaluation, software validation, shelf life testing, electromagnetic compatibility and electrical safety testing. While the Classification Order has been released by FDA, we look forward to posting more info about the details of the testing that NeuroSigma provided in their de novo once the Decision Summary is made public.
4. About ADHD