Real-world efficacy of deep TMS for obsessive-compulsive disorder: interim post-marketing analysis of 192 patients from twenty-two sites

Background: Deep transcranial magnetic stimulation (dTMS) with the H7-coil was FDA cleared for obsessive-compulsive disorder (OCD) in August 2018 based on multicenter sham-controlled studies but the efficacy in real world practices is not known. Methods: All dTMS clinics were asked to supply their data on details of treatment details and outcome measures. The primary outcome measure was response, defined by at least a 30% reduction in the Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline to endpoint. Secondary outcome measures included first response, defined as the first time the YBOCS score has met response criteria, and sustained response, defined as when two consecutive YBOCS scores met response criteria. Analyses included response rate at endpoint, after 29 dTMS sessions, number of sessions and days required to reach first and sustained response. Results: 22/175(13%) clinical sites with H7-coils provided data on details of treatment and outcome (YBOCS) measures from a total of 192 patients. One-hundred-eighty patients who had at least one post-baseline YBOCS measure were included in the analyses. Endpoint first and sustained response rates were 73.2% and 62.2%, respectively. The response rate was 58% after 29 dTMS sessions. First response was achieved in average after 18 sessions (SD=9.4) or 28 days (SD=22.4). Sustained response was achieved after 19 sessions (SD=9.6) or 30 days (SD=24.5). Average YBOCS scores demonstrated continuous reduction with increasing numbers of dTMS sessions. Conclusions: Most OCD patients benefit from dTMS, and improvement usually starts within 20 sessions. Extending the treatment course beyond 29 sessions results in continued reduction of OCD symptoms, raising the prospect of value for extended treatment protocols in non-responders. Funding: BrainsWay Disclosures: Aron Tendler, Abraham Zangen, Yiftach Roth and Tal Harmelech have a financial interest in BrainsWay. Aron Tendler, Kemal Arikan, Mark DeLuca, Ryan Vidrine, David Kent, Owen Muir, Carlene MacMillan, Leah Casuto, Deborah Kim, Brent Peterson, Geoffrey Grammer, William Sauve, Kellie Tolin, Steven A. Harvey, Misty Borst, Robert Rifkin, Manish Sheth, Brandon Cornejo, Raul Rodriguez, Saad Shakir, Taylor Porter, Piper Buersmeyer, Julia Swofford and Brendan Roe have a financial interest in commercial TMS.