NCT07116785

Accelerated Rotational Field Deep TMS for Treating OCD

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ben-Gurion University of the Negev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a randomized, double-blind clinical trial designed to compare the efficacy of active rfTMS coil targeting the mPFC and ACC with an inactive sham treatment. Conducted over a 13-week period, the trial includes 39 treatment sessions following an accelerated protocol. Eligible participants are randomly assigned in a 1:1 ratio to either the active treatment or sham group. Each daily treatment comprises three sessions separated by 1-hour intervals, resulting in a total treatment duration of 2.5 hours per day. The treatment regimen is structured into three distinct phases (Figure 1): (1) an acute phase (week 1), in which participants are treated for five consecutive days (totaling 15 sessions); (2) a maintenance phase (weeks 2-6), during which participants are treated once per week for five weeks (totaling 15 sessions); and (3) a follow-up phase during which participants are treated every visit at weeks 8, 10, and 13 (totaling 9 sessions). Imaging sessions are conducted at baseline and at the end of the maintenance session.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	BrainsWay Deep TMS HAC/H7-Coil	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.
DEVICE	BrainsWay Deep TMS Sham Coil	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.

Timeline

• Start date: 2023-09-19
• Primary completion: 2027-06-14
• Completion: 2028-12-14
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: Israel