A US$2.5m NIH grant will test accelerated deep TMS for alcohol use disorder in a five-year, 100-patient clinical trial.
Deep TMS is a non-invasive brain stimulation that uses magnetic pulses via a specialised coil to modulate activity in targeted brain circuits.
The study will use BrainsWay’s H7 coil and an intensive schedule: three sessions per day over 10 business days (30 sessions). It is a randomised, double-blind, sham-controlled design with neuroimaging to assess “target engagement” in regions such as the dorsal anterior cingulate cortex. Outcomes include days abstinent and heavy drinking days.
The trial is led by principal investigator Dr Claudia Padula and co-investigator Dr Michelle Madore, working across Stanford University and the Palo Alto Veterans Institute for Research.
“This accelerated treatment protocol represents a substantial leap forward in our research on AUD,” said Dr Colleen Hanlon, vice president of medical affairs at BrainsWay. “If we can confirm that this rapid, high-intensity Deep TMS protocol effectively and durably engages the targeted brain circuits and reduces relapse risk, it has the potential to facilitate the development of new, much-needed neuromodulation-based treatment strategies for AUD.”
The team previously received a multimillion-dollar NIH award, with a US$1.49m first-year budget, to study a similar accelerated protocol using the H4 coil for stimulant (methamphetamine) use disorder, primarily in veterans.
“We are excited to see clinical studies evaluating the use of accelerated Deep TMS being conducted by such highly distinguished researchers,” said Hadar Levy, chief executive officer of BrainsWay. “If successful, the findings from the MUD and AUD studies may lead to significantly expanded adoption of advanced, non-invasive neuromodulation techniques to treat substance use disorders.”
BrainsWay also recently reported FDA clearance for its H1 coil for an accelerated protocol in major depressive disorder, including patients with comorbid anxiety symptoms.
