FDA-Cleared Brain Stimulation Device For ADHD Works No Better Than Placebo In Major Trial

FDA-Cleared Brain Stimulation Device For ADHD Works No Better Than Placebo In Major Trial

The study tested external trigeminal nerve stimulation, or TNS, which works by sending electrical pulses through patches placed on the forehead during sleep. The post FDA-Cleared Brain Stimulation Device For ADHD Works No Better Than Placebo In Major Trial appeared first on StudyFinds.

FDA-cleared brain stimulation device fails to beat placebo in ADHD trial

A large-scale clinical trial has determined that a specific brain stimulation device, previously cleared by regulators for treating attention-deficit/hyperactivity disorder, does not effectively reduce core symptoms in children and adolescents. The study suggests that positive outcomes reported in earlier, smaller trials were likely driven by the placebo effect rather than the electrical stimulation itself. These findings were published in Natur…

Brain stimulation device cleared for ADHD in the US is overall safe but ineffective

A large multicentre clinical trial led by King’s College London with 150 children and adolescents has shown that a device cleared by the US FDA to treat ADHD is not effective in reducing symptoms.    The device – which uses an approach called trigeminal nerve stimulation (TNS) – was cleared for use by the US Food and Drugs Administration (FDA) to treat ADHD in 2019 based on a small study. These new findings from a larger multicentre trial, publi…