- Trial to be conducted at UCLA and funded by a grant from National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- First phase of trial will enroll up to 30 children ages 8 – 12 with exposure to alcohol during gestation to receive treatment with the Monarch
- Upon successful completion of Phase I, investigators will proceed with a larger, double-blind randomized crossover trial
LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for treating ADHD, today announced a new clinical trial of the Monarch for treating symptoms of ADHD in children with fetal alcohol syndrome (FAS). The 2-year trial will be led by Professor Joseph O’Neill, Adjunct Professor of Psychiatry at UCLA, and is being funded by an initial $350,000 grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA). Monarch devices and supplies for the trial will be provided by NeuroSigma.
Repeated exposure to alcohol during gestation is associated with a significantly increased risk of learning and behavioral problems during childhood. These children tend to develop symptoms similar to ADHD such as hyperactivity, impulsivity, and executive function deficits. Children with FAS also tend to be less responsive to conventional ADHD therapies, such as stimulant medications, which can lead to worse outcomes, and increases the need for new approaches to treating this vulnerable population.
In its first phase, the trial will enroll up to 30 children ages 8 – 12 with exposure to alcohol during gestation and exhibiting symptoms of ADHD. The children will receive nightly therapy with the Monarch for 4 weeks, and parents will keep track of their children’s ADHD symptoms, sleep habits, adverse events, and tolerability of the therapy during the 4-week treatment period. The primary goal of Phase I is to demonstrate feasibility. If successful, investigators will proceed with a larger, double-blind randomized crossover trial.
“NeuroSigma is thrilled to work with leading medical professionals and scholars in the field of child psychiatry to expand the indications for our proprietary Monarch eTNS therapy. We are grateful to Professor O’Neil and his colleagues for commencing this innovative and important clinical trial,” commented Colin Kealey, M.D., President and CEO of NeuroSigma, adding, “We would also like to thank the NIAAA for their generous grant that will support this work. According to the CDC, up to 1 in 20 school aged children may suffer from fetal alcohol spectrum disorders, and our goal is that the Monarch will provide patients, caregivers, and healthcare providers with a new option for treating this underserved population.”
Families interested in participating in the clinical trial may email the study at ChildBrainStudy@mednet.ucla.edu, call at (310) 267-2710, or fill-out an online screener to determine eligibility.
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.
Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com
