RecruitingNot ApplicableNCT07116785

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


Sponsor

Ben-Gurion University of the Negev

Enrollment

50 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an accelerated version of deep TMS (transcranial magnetic stimulation) — a non-invasive brain stimulation procedure — using a rotating magnetic field to treat obsessive-compulsive disorder (OCD) in people who have not responded well to standard treatments. **You may be eligible if...** - You have been diagnosed with OCD (according to DSM-5 criteria) - Your OCD symptoms are moderately severe or worse (Y-BOCS score above 20) - If you are on medication for OCD, you have been at a stable dose for at least 2 months - You are willing and able to attend all treatment sessions **You may NOT be eligible if...** - You have another primary psychiatric diagnosis - Your other psychiatric conditions are unstable - You have active suicidal thoughts or recent suicide attempts - You have metal implants in your head, a pacemaker, or seizure history - You are not compliant with your current medication regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBrainsWay 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.

DEVICEBrainsWay 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.


Locations(1)

Soroka University Medical Center

Beersheba, Israel

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NCT07116785


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