NeuroSigma, Inc. announced the completion of enrollment for the ATTENS trial, a multicenter, double-blind, placebo-controlled study evaluating the effectiveness of its Monarch® eTNS System for treating ADHD in children and adolescents. The trial, funded by the UK’s National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC), enrolled 150 participants aged 8-18 who were randomized to receive either active or sham eTNS therapy for four weeks. Data collection, including fMRI neuroimaging, clinical and cognitive assessments, and autonomic nervous system function measurements, will continue until March 2025.
This trial’s completion is crucial for advancing non-pharmaceutical ADHD treatment options. Current pharmacological interventions are not always effective or well-tolerated, leading to a significant unmet need for alternative therapies. The robust enrollment figures suggest substantial public interest in exploring non-drug solutions for ADHD, highlighting the trial’s potential impact on patient care. Furthermore, the study’s comprehensive data collection, particularly the inclusion of fMRI neuroimaging, promises to provide valuable insights into the mechanism of action of eTNS therapy. This information could significantly improve our understanding of how eTNS impacts brain activity and contributes to symptom reduction in ADHD.
The ATTENS trial represents the largest clinical investigation of the Monarch eTNS System to date, significantly expanding the existing clinical dataset. The trial is evaluating the improvement of ADHD symptoms using the ADHD-RS-V scale, a gold standard measure in ADHD clinical research. The involvement of prestigious institutions like King’s College London and the University of Southampton, coupled with the support from NIHR and MRC, lends further credibility to the study.
The results of this trial, expected in March 2025, are poised to shape the future of eTNS therapy for ADHD. Positive findings could solidify the Monarch eTNS System’s position as a viable alternative or complementary treatment to existing pharmacological options, potentially transforming clinical practice and improving the lives of individuals with ADHD. The detailed mechanistic data will also be invaluable for informing future research and development in this field, paving the way for refined and more targeted eTNS interventions for ADHD and other neurological conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
