
NeuroSigma's Monarch eTNS System as the first non-drug treatment for pediatric ADHD approved by the FDA.
Photo Credit:NeuroSigma Inc.
Scientific Frontline: "At a Glance" Summary
- Main Discovery: A large multicentre clinical trial determined that the Monarch external Trigeminal Nerve Stimulation (eTNS) system, a device cleared by the US FDA for treating ADHD, is ineffective at reducing symptoms despite being safe to use.
- Methodology: Researchers conducted a randomized, double-blind, sham-controlled trial involving 150 children and adolescents (ages 8–18) across two UK sites, assigning participants to receive either active nightly stimulation or a credible sham (placebo) stimulation over a four-week period.
- Key Data: The active group received approximately 9 hours of stimulation nightly, while the sham group received only 30 seconds of non-therapeutic pulses per hour; analysis showed no statistically significant difference in ADHD symptom reduction or secondary outcomes like sleep and mood between the two groups.
- Significance: The findings directly challenge the validity of the smaller, unblinded pilot study used for the device's 2019 FDA clearance, highlighting the critical role of rigorous placebo controls in ruling out expectation effects in medical device trials.
- Future Application: Regulatory bodies are advised to re-evaluate the evidence supporting the device's clearance to prevent patients and families from investing in treatments that do not provide clinical benefit.
- Branch of Science: Clinical Neuroscience and Pediatric Psychiatry
- Additional Detail: Unlike the previous pilot study which failed to maintain blinding, this trial successfully blinded participants to their condition, suggesting the earlier reported benefits were likely driven by the placebo effect.





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