Brainsway ((BWAY)) announced an update on their ongoing clinical study.
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Study Overview: Brainsway (BWAY) is conducting a study titled A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Reducing Heavy Alcohol Drinking in Individuals With Alcohol Use Disorder (AUD). The study aims to assess the safety and effectiveness of Deep TMS in reducing heavy alcohol consumption among individuals diagnosed with moderate to severe Alcohol Use Disorder (AUD), a significant public health concern.
Intervention/Treatment: The study tests the Deep Transcranial Magnetic Stimulation (Deep TMS) device, which is designed to reduce heavy drinking in individuals with AUD. Participants in the treatment group receive active Deep TMS sessions, while the control group receives sham (inactive) treatments.
Study Design: This is a randomized, double-blind, sham-controlled, multicenter trial. Participants are randomly assigned to either the treatment or control group, ensuring unbiased results. The study employs a triple-masking approach, meaning the participants, care providers, and investigators are unaware of group assignments. The primary goal is to evaluate the treatment’s effectiveness in reducing heavy drinking days.
Study Timeline: The study is set to begin on October 12, 2025, with the primary completion date yet to be determined. The last update was submitted on the same date, indicating the study is in its initial stages and not yet recruiting participants.
Market Implications: This study could significantly impact Brainsway’s stock performance, as positive results may boost investor confidence and market share in the medical device sector. Given the high prevalence of AUD, successful treatment options like Deep TMS could position Brainsway favorably against competitors in the mental health treatment industry.
The study is ongoing, with further details available on the ClinicalTrials portal.