A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of Accelerated BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) Protocol in Obsessive-Compulsive Subjects
Sponsor study identifier
Secondary identifiers
REGISTRY · Soroka University Medical Center Institutional Registry
interventional
50
1 country
1
Study Start
September 19, 2023
Actual (reported)Primary Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 14, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2023
Actual (reported)August 7, 2025
Actual (reported)August 12, 2025
Actual (reported)June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 14, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Yale Brown Obsessive Compulsive Scale (YBOCS)
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
6 weeks
Yale Brown Obsessive Compulsive Scale (YBOCS)
13 weeks
Rotational field TMS (rfTMS) is a novel technology where two orthogonal coils are operated with a 90 phase shift between them. The combined electric field vector of rfTMS from both coils rotates up to a complete cycle during the TMS pulse. This method overcomes the inherent limitation of conventional unidirectional TMS by influencing neurons in various orientations (Roth et al., 2020b). This unique advance bears enormous potential for therapeutic applications in various neuropsychiatric disorders. The coil Array includes the H7 coil as the lower coil, and an upper coil perpendicular to it. Hence, the HAC/H7 coil Array induces similar electric field distribution and affects the same brain structures as the H7 coil, but stimulates neurons in various orientations within these regions.
Soroka University Medical Center
Beersheba, 8410101, Israel
Shukrun D, Shalev H, Gulevsky T, Harel M, Zangen A. Distinct structural abnormalities in obsessive-compulsive and alcohol use disorders. Eur Arch Psychiatry Clin Neurosci. 2026 Sep 19. doi: 10.1007/s00406-026-02375-y. Online ahead of print.
Abraham Zangen, Prof.
Ben-Gurion University of the Negev
First Submitted
August 7, 2025
First Posted
August 12, 2025
Study Start
September 19, 2023
Actual (reported)Participants assigned to this intervention will receive sham stimulation using a BrainsWay Deep TMS sham coil that mimics the sensation and acoustic properties of active stimulation but does not deliver effective magnetic pulses to the brain. This condition is used as a placebo control to blind participants and investigators.
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Primary Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 14, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 12, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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