The US Food and Drug Administration (FDA) has permitted marketing for the Monarch external Trigeminal Nerve Stimulation (eTNS) System, a new medical device to treat attention deficit hyperactivity disorder (ADHD).
The device marks the first non-drug treatment for ADHD, and is indicated for patients ages seven to12 years old who are not currently taking prescription ADHD medication.
The system is for use in the home, under the supervision of a caretaker. The mobile 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, and should feel like a tingling sensation on the skin.
It then delivers the low-level electrical stimulation to 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.
The decision is based on a clinical trial that showed that the average ADHD-RS score - a clinician-administered ADHD Rating Scale - in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.
“This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, 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 paediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”
ADHD is a common disorder that begins in childhood, with symptoms including difficulty staying focused and paying attention, difficulty controlling behaviour and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional.