Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial
Publication: American Journal of Psychiatry
Abstract
Objective:
Obsessive-compulsive disorder (OCD) is a chronic and disabling condition that often responds unsatisfactorily to pharmacological and psychological treatments. Converging evidence suggests a dysfunction of the cortical-striatal-thalamic-cortical circuit in OCD, and a previous feasibility study indicated beneficial effects of deep transcranial magnetic stimulation (dTMS) targeting the medial prefrontal cortex and the anterior cingulate cortex. The authors examined the therapeutic effect of dTMS in a multicenter double-blind sham-controlled study.
Methods:
At 11 centers, 99 OCD patients were randomly allocated to treatment with either high-frequency (20 Hz) or sham dTMS and received daily treatments following individualized symptom provocation, for 6 weeks. Clinical response to treatment was determined using the Yale-Brown Obsessive Compulsive Scale (YBOCS), and the primary efficacy endpoint was the change in score from baseline to posttreatment assessment. Additional measures were response rates (defined as a reduction of ≥30% in YBOCS score) at the posttreatment assessment and after another month of follow-up.
Results:
Eighty-nine percent of the active treatment group and 96% of the sham treatment group completed the study. The reduction in YBOCS score among patients who received active dTMS treatment was significantly greater than among patients who received sham treatment (reductions of 6.0 points and 3.3 points, respectively), with response rates of 38.1% and 11.1%, respectively. At the 1-month follow-up, the response rates were 45.2% in the active treatment group and 17.8% in the sham treatment group. Significant differences between the groups were maintained at follow-up.
Conclusions:
High-frequency dTMS over the medial prefrontal cortex and anterior cingulate cortex significantly improved OCD symptoms and may be considered as a potential intervention for patients who do not respond adequately to pharmacological and psychological interventions.
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Information & Authors
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History
Received: 16 October 2018
Revision received: 18 February 2019
Accepted: 12 March 2019
Published online: 21 May 2019
Published in print: November 01, 2019
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Funding Information
US Dept of Veterans Affairs: I21 RX002032, IK2 CX001824
Supported by Brainsway Ltd.Dr. Carmi has received research and travel support from Brainsway. Dr. Tendler serves as the chief medical officer of and has a financial interest in Brainsway, and he has ownership interest in Advanced Mental Health Care, Inc. Dr. Bystritsky is an investigator on and receives grant support for several clinical trials by Brainsway. Dr. Hollander receives grant support from Brainsway. Dr. Blumberger has received research support from the Canadian Institutes of Health Research, NIH, Brain Canada, the Patient-Centered Outcomes Research Institute, the Weston Brain Institute, and the Temerty Family through the Centre for Addiction and Mental Health Foundation and the Campbell Research Institute; he receives research support and in-kind equipment support for an investigator-initiated study from Brainsway and is the site principal investigator for three sponsor-initiated studies for Brainsway; he receives in-kind equipment support from Magventure for an investigator-initiated study; he has received medication supplies for an investigator-initiated trial from Indivior; and he has participated on an advisory board for Janssen. Dr. Daskalakis has received research and in-kind equipment support for an investigator-initiated study through Brainsway and Magventure; his work was supported by the Ontario Mental Health Foundation, the Canadian Institutes of Health Research, NIMH, and the Temerty Family and Grant Family and through the Centre for Addiction and Mental Health Foundation and the Campbell Institute. Dr. Lapidus has received research support from the Brain and Behavior Research Foundation, the Education and Research Foundation for Nuclear Medicine and Molecular Imaging, the Le Foundation, NIMH, and the Simons Foundation; he has received devices, meals, travel support, and research support from Brainsway, Halo Neuroscience, Medtronic, Neuronetics, and Roche; he has served as a consultant for Cipla, FCB Health, LCN Consulting, SmartAnalyst, and Third Bridge; he founded New York Neuromodulation Medical and Sol2rise and has ownership interest in Victory Recovery Partners, in Halo Neuroscience (for whom he also serves on the advisory board), and Validose (for whom he also serves as chief medical officer); and he is named on a patent application for an intranasal medication administration device for Validose, which develops products related to this patent. Dr. Goodman has served as a consultant for Biohaven Pharma. Dr. Feifel has received advisory board travel support from Brainsway. Dr. Roth is a key inventor of deep TMS and has a financial interest in Brainsway. Prof. Zangen has a financial interest in Brainsway. Dr. Zohar has received grant and research support from Brainsway, Lundbeck, and Servier, and he has served as a consultant, on advisory boards, or on speakers bureaus for Abbott, Actelion, Brainsway, Eli Lilly, Lundbeck, Pfizer, Roche, Servier, and Sun Pharma. The other authors report no financial relationships with commercial interests.Metrics & Citations
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