NeuroSigma Announces King’s College London Team Receives MHRA Approval to Commence Largest Clinical Trial of eTNS for Pediatric ADHD to Date

NeuroSigma, Inc., a bioelectronic medical device company, today announced that a team at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to commence the largest trial of external Trigeminal Nerve Stimulation (eTNS) ever conducted. The clinical trial will be led by Professor Katya Rubia, a Professor of Cognitive Neuroscience at King’s IoPPN, and is funded by a £1.9 million award from a partnership between the UK’s National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The multicenter trial will enroll up to 150 children with moderate to severe ADHD and randomize them to receive active or sham eTNS for a four-week blinded period. Participants’ response to treatment will be assessed via parent, and teacher rating scales, as well as cognitive tests. A subgroup of approximately 58 children will receive functional magnetic resonance imaging (fMRI) at baseline and after four weeks of therapy.

“We would like to thank Professor Rubia and her team at King’s IoPPN who led these efforts, as well as the UK’s NIHR and MRC for providing funding, and the MHRA for approval to commence enrollment,” said Dr. Colin Kealey, President of NeuroSigma. “This will be the largest clinical trial of eTNS ever conducted that will be able to test the safety and efficacy of eTNS for pediatric ADHD.”

ADHD is one of the most common neurodevelopmental disorders affecting approximately 7% of children worldwide. It is typically treated with medication, most commonly stimulants, but these often carry significant side effects and don’t work for all patients. In 2019, NeuroSigma’s Monarch eTNS System became the first-ever non-pharmaceutical treatment to receive FDA clearance as a treatment for pediatric ADHD. To deliver therapy with the Monarch, patients place an adhesive electric patch on their forehead. The patch is then connected to a handheld pulse generator that delivers a mild electrical current to the V1 division of the trigeminal nerve that is located just beneath the surface of the skin.

“I am very excited to soon start enrolling patients in this clinical trial,” commented Professor Katya Rubia. “There is a clear need for safe and effective non-drug treatments for ADHD. This will also be the first clinical trial of eTNS to use fMRI to better understand the therapy’s mechanism of action. If successful, this trial will dramatically expand the evidence base supporting use of eTNS in this patient population and also help us better understand how the therapy exerts its effect. Such data could be used to predict which patients might respond prior to initiating therapy as well as other potential indications for eTNS.”