New Clinical Trial of eTNS for Pediatric ADHD to Commence at Denmark’s Center for Evidence-Based Psychiatry

/EIN News/ -- LOS ANGELES, Dec. 11, 2024 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company, announced today that the Center for Evidence-Based Psychiatry (CEBP) in Denmark has approved commencing enrollment of a clinical trial of NeuroSigma’s Monarch^® eTNS System for treating pediatric attention-deficit hyperactivity disorder (ADHD). The trial, to be conducted at several Danish child and adolescent psychiatry centers, is being led by Professor Ole Jakob Storebø, principal investigator and head of the CEBP. The trial is funded by the government of Denmark, Region Zealand's Health Sciences Research Foundation, Region Southern Denmark Research Foundation, AP Møller, and the Jascha Foundation. The Monarch eTNS System employs external trigeminal nerve stimulation (eTNS) for treating neuropsychiatric conditions, and NeuroSigma is currently commercializing the medical device in the United States for treating pediatric ADHD.

The clinical trial is divided into two phases. During the first phase, up to 60 subjects, ages 7 to 17 with ADHD will be enrolled at four sites in Denmark to receive active or sham eTNS treatment for a period of 4 weeks. The primary purpose of the first phase is to assess the feasibility of eTNS as a treatment for ADHD. The primary exploratory endpoint of the first phase will be the change in core ADHD symptoms in the active group as compared to sham group after 4 weeks of treatment. Secondary exploratory endpoints will include cognitive function, autonomic nervous system function, sleep quality and overall severity and change in clinician-rated symptoms. If the first phase of the trial demonstrates feasibility, then the investigators intend to proceed with a larger trial of 200 additional subjects. Enrollment of the trial’s first phase is planned to commence in December of 2024.

“We are excited to commence enrollment in this important clinical trial of eTNS as a treatment for children and adolescents with ADHD,” said Professor Storebø. “The clinical trials of eTNS to date have focused on pediatric populations using the device as monotherapy. In this trial, we will extend the age range to 17 and include patients that will use the device as an adjunct to stimulant medications.”

"We are grateful to the Danish government, the other funders, and Professor Storebø for funding and organizing this new clinical trial of eTNS as a treatment for ADHD,” remarked Colin Kealey, M.D., President and CEO of NeuroSigma. “NeuroSigma’s goal is to fundamentally change the ADHD treatment landscape by including our proprietary Monarch eTNS System alongside conventional pharmaceutical-based therapies. The data generated by Professor Storebø and his colleagues will complement the ongoing trials at King’s College London and University of California, Los Angeles, contributing to NeuroSigma’s world-class dataset on the safety and efficacy of eTNS treatment for ADHD.”

About NeuroSigma

NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company’s lead product is the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch include neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.

About the Center for Evidence Based Psychiatry (CEBP)

The CEBP, based in Region Zealand, Denmark, strengthens evidence-based prevention, diagnosis, and treatment in Psychiatry. Its tasks include reviews, clinical trial support, guideline development, and teaching to ensure high-quality mental health interventions.

Contact:
Colin Kealey, M.D., President & CEO NeuroSigma
CKealey@neurosigma.com