Accelerated Rotational Field Deep TMS for Treating OCD

NCT07116785 | Recruiting

• 1 other identifier: 0140-22-SOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep TMS; Rotational Field

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale (YBOCS)

  13 weeks

Study Arms (2)

Active TMS

EXPERIMENTAL

Device: BrainsWay Deep TMS HAC/H7-Coil

Sham TMS

SHAM COMPARATOR

Device: BrainsWay Deep TMS Sham Coil

Interventions

BrainsWay Deep TMS HAC/H7-Coil DEVICE

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.

Active TMS

BrainsWay Deep TMS Sham Coil DEVICE

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.

Sham TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• Diagnosed as suffering from OCD according to the DSM-V.
• Subjects with a YBOCS score of \>20.
• If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
• If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
• Have negative or justified responses by the investigator to all questions listed on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
• According to the treating physician the subject is compliant with taking medication, if applicable.
• Subject is capable and willing to provide informed consent and assent.
• Willing and able to adhere to the treatment schedule.
• All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.

You may not qualify if:

• Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
• Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
• Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
• History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
• Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
• History of head injury necessitating cranial surgery or prolonged coma.
• History of any ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
• Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
• History of significant hearing loss.
• Subjects with significant neurological disorder or insult
• Substance use disorder within the past 6 months (except nicotine and caffeine and based on the doctor's judgment).
• Currently participating in another therapeutic clinical study.
• Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
• Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
• Significant possibility of death within eighteen months of baseline.

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead
• Brainsway: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, 8410101, Israel

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Abraham Zangen, Prof.

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dor Shukrun, PhD Student

CONTACT

+972547551542; dor.yshukrun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: This is a two-arm, parallel assignment, randomized controlled trial comparing the effects of accelerated rotational-field deep transcranial magnetic stimulation versus sham stimulation in patients with OCD

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: September 19, 2023
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): December 14, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

IL (1)