The U.S. Food and Drug Administration (FDA) recently announced it is giving the OK for the first medical device to treat attention-deficit/hyperactivity disorder (ADHD) in children. The device is created by Los Angeles, California-based life sciences organization NeuroSigma. NeuroSigma, Inc. is currently working on trigeminal nerve stimulation for a variety of disorders, including ADHD, epilepsy, depression, post-traumatic stress disorder, Lennox-Gastaut syndrome, and traumatic brain injury.
NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) System, is a device that is intended for children ages 7 to 12 who are not currently receiving prescription medication for ADHD. The device can be used at-home and without adult supervision, and involves a wire that is connected to a small patch that is placed on the child’s forehead, generating low-level electrical pulses to their brain.
The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, dietary supplements, medications, vaccines, biopharmaceuticals, medical devices, and other products. These pulses are intended to increase activity in regions of the brain that are known to be important in relation to the regulation of attention, behavior, and emotion.
NeuroSigma, Inc. is developing trigeminal nerve stimulation for a variety of disorders, including epilepsy, depression, attention-deficit/hyperactivity, post-traumatic stress disorder, Lennox-Gastaut syndrome, and traumatic brain injury.
This was reported by USA Today on April 18, 2019.
Contact Information: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993; (888) 463-6332; Website: www.fda.gov
Contact Information: NeuroSigma, Inc., 10960 Wilshire Boulevard, Suite 1910, Los Angeles, California 90024; (310) 479-3100; Website: www.neurosigma.com