The Food and Drug Administration has approved the first device designed to treat Attention Deficit Hyperactivity Disorder (ADHD) in children. The device is only available as a prescription, offering the public a non-drug alternative to treat the condition. Key to the device is technology that delivers mild stimulation to the patient’s trigeminal nerve.
The device is called the Monarch external Trigeminal Nerve Stimulation (eTNS) System; it is around the size of a cell phone and can be used with patients ages 7 to 12, according to the FDA, which announced its approval of the device on Friday. This is the first non-drug treatment for childhood ADHD that has been approved for marketing by the administration.
The stimulation device features a small patch that is placed on the patient’s forehead; it is connected with the Monarch eTNS System via a wire and delivers stimulation to the trigeminal nerve branches. This stimulation is described as feeling like tingling. Past research has indicated that use of this device boosts activity in parts of the brain associated with regulating ADHD symptoms.
The device is used while the child is asleep under the supervision of a caregiver. There are some side effects that can result from using the device, according to the FDA, including headaches, fatigue, sleeping issues, higher appetite, and teeth clenching.
The FDA’s Director of Neurological and Physical Medicine Devices Carlos Pena, PhD, explained:
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. 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.