BrainsWay Ltd. announced results from a randomized controlled double-blind clinical trial (NCT01196910) assessing the safety and efficacy of the Company’s proprietary H6-coil deep transcranial magnetic stimulation (dTMS) System for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Researchers at Tel Aviv Sourasky Medical Center, Tel Aviv University, Ben Gurion University, and BrainsWay conducted the study, which used functional magnetic resonance imaging to assess the effect of dTMS on clinical, cognitive and neural activity in adults with ADHD. Results showed a statistically significant improvement in self-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex, a part of the brain previously shown to have reduced activity in adults with ADHD. Overall, this study adds to the growing body of clinical evidence demonstrating the potential clinical benefits of dTMS in the treatment of ADHD.
The study enrolled 75 adults, ages 18-60 years, with ADHD who had not previously received TMS. The study included one treatment group with the coil placed over the right DLPFC (N=27), a second group with the coil placed over the left DLPFC (N=28), and a sham group (N=20). Participants underwent a treatment phase consisting of 15 daily dTMS sessions, which were conducted five days a week for three consecutive weeks using the BrainsWay dTMS H6-coil. Each individual underwent fMRI before and after the treatment phase. Two additional treatment sessions were performed at the second and third follow-up visits (after eight and 12 weeks, respectively). At each treatment session, participants also performed six minutes of computerized cognitive training consisting of an immediate recall task and a sustained attention task, each of three-minute duration. Participants also underwent clinical evaluation at screening, after the three-week treatment phase, and then at four and eight weeks after completion of the treatment phase, which included symptom assessment using validated questionnaires, and a full cognitive assessment including evaluation of memory, executive function and attention skills.
BrainsWay is engaged in the research, development, and sales and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique breakthrough technology called Deep TMS, which can reach significant depth and breadth of the brain and produce broad stimulation and functional modulation of targeted brain areas. In the U.S., the Company’s device has been FDA cleared for the treatment of major depressive disorder and obsessive compulsive disorder.
This was reported by BrainsWay on February 10, 2020.