Data presented at the American Academy of Child and Adolescent Psychiatry annual meeting indicated efficacy of monotherapy external trigeminal nerve stimulation for ADHD in children.
“ADHD is estimated to affect 9.5% of school age children and 4.4% of adults, and our current treatments primarily include psychostimulant medications and behavioral therapies. While there is great demand for nonmedication approaches to ADHD, most popular alternatives are not linked to any mechanistic understanding of brain processes and similarly lack significant scientific evidence to support their use,” study researcher James McGough, MD, MS, of the University of California, Los Angeles, said in a press release. “I am excited to have found a significant improvement in ADHD symptoms in our double-blind randomized clinical trial of this neuromodulation treatment.”
To assess efficacy of external trigeminal nerve stimulation (eTNS) as monotherapy for ADHD, researchers conducted a randomized clinical trial among 62 children aged 8 to 12 years. Study participants were randomly assigned to use eTNS at home each night for 4 weeks.
Participants who received eTNS exhibited statistically significant improvement in ADHD symptoms, compared with participants who received a sham intervention (P = .005).
The eTNS group also exhibited statistically significant improvement on the CGI-I scale, compared with the sham group (P = .003).
Adverse effects were generally mild and transient, according to researchers.
“The core value proposition of eTNS is effective nonpharmacological treatment with minimal side-effects. We are very pleased with the results of this double-blind trial and applaud the dedication and efforts of the UCLA team,” Leon Ekchian, PhD, president and CEO of NeuroSigma, said in the release. “Following FDA approval, we look forward to offering parents a nonpharmacological treatment option for pediatric ADHD in the United States.”