The U.S. Food and Drug Administration (FDA) allows the usage of an electric ‘shock’ device to treat children with attention deficit hyperactivity disorder (ADHD). The device is called as the Monarch External Trigeminal Nerve Stimulation System (eTNS), which is developed by NeuroSigma, Inc., a bioelectronics company based in Los Angeles. FDA has permitted the marketing of this electric stimulator, which is the first device that does not involve any drugs for the treatment of patients. The company is now free to sell and advertise the device as an effective treatment for ADHD in children.
Dr. Leon Ekchian, the CEO & President of NeuroSigma stated that his company is extremely delighted by FDA's approval of the Monarch eTNS for treating ADHD in children. The company is thankful to the FDA team for their efforts throughout the review process to bring it to a timely and successful completion. In addition, the company appreciates the hard work of the medical team at University of California, Los Angeles (UCLA). Ekchian added that the company wishes to build a commercial organization in the U.S. to provide the children, their parents and physicians with a low-risk, compelling, and non-drug option to treat ADHD.
Technological developments and new product launches have been a recent trend in the electrical stimulation therapy industry. According to Big market research, there will be a progressive growth in global electrical stimulation therapy market in the coming years. The newly developed device uses an electrical stimulation therapy to treat children in the age group of 7 to 12 years, suffering from ADHD. It is a substitute to prescription medicines, and effective in managing behavior and enhancing attention in hyperactive children. The system is advised to be used at home only under the observation of a caretaker. The effects of the treatment are visible in about a month.
The device has a wire with an adhesive patch at the other end, which is to be placed on the patient’s forehead above the eyebrows while the patient is sleeping. It sends mild electrical impulses to areas of the brain that is responsible for causing ADHD. These electrical stimulations are delivered to the branches of cranial nerve that carries sensations from the face to the brain.
Carlos Peña, the Director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health stated that the new device is a safe and non-drug option, which uses mild nerve stimulation for treating children suffering with ADHA.