Accelerated rotational-field deep TMS for obsessive-compulsive disorder

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

This will try a short, accelerated course of BrainsWay rotational-field Deep TMS to reduce symptoms in adults with moderate-to-severe OCD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ben-Gurion University of the Negev (Academic / other)
• Locations: 1 site (Beersheba)
• Trial ID: NCT07116785 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind trial comparing active rotational-field Deep TMS targeting the medial prefrontal cortex and anterior cingulate with a sham coil over 13 weeks. Participants are randomized 1:1 and receive a total of 39 sessions following an accelerated protocol that includes an initial five-day acute phase of three daily sessions, a five-week maintenance phase with once-weekly sessions, and follow-up visits at weeks 8, 10, and 13. Each daily treatment day during the acute phase consists of three sessions separated by one-hour intervals, and imaging is obtained at baseline and after the maintenance phase. The trial uses BrainsWay H-coils for active stimulation and matched sham coils for blinding.

Who should consider this trial

Good fit: Ideal candidates are outpatients diagnosed with OCD by DSM-5 criteria who have a Y-BOCS score over 20, are stable on any SRIs for at least two months or in maintenance CBT, pass TMS safety screening, and can attend frequent in-person sessions.

Not a fit: Patients with mild OCD (Y-BOCS ≤20), those actively undergoing exposure-and-response-prevention training, people with contraindications to TMS (e.g., certain implanted devices), or those unable to commit to repeated clinic visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive, time-efficient option that reduces OCD symptoms and maintains benefit over several months.

How similar studies have performed: Previous trials and regulatory clearance for Deep TMS (H7 coil) have shown benefit for OCD, but the specific accelerated rotational-field protocol is a newer variation with more limited prior data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Planned surgeries that will interrupt the study schedule within four months of baseline.
* Women who are breast-feeding.
* Women who are pregnant or with suspected pregnancy.
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.

Where this trial is running

Beersheba

• Soroka University Medical Center — Beersheba, Israel (Recruiting)

Study contacts

• Principal investigator: Abraham Zangen, Prof. — Ben-Gurion University of the Negev
• Study coordinator: Dor Shukrun, PhD Student

Conditions Obsessive-Compulsive Disorder; Deep TMS; Rotational Field