NCT07116785 Accelerated Rotational Field Deep TMS for Treating OCD
| NCT ID | NCT07116785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ben-Gurion University of the Negev |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2027-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-09-19 with a primary completion date of 2027-06-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Abraham Zangen, Prof.
PRINCIPAL INVESTIGATOR
Ben-Gurion University of the Negev
Frequently Asked Questions
Who can join the NCT07116785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116785 currently recruiting?
Yes, NCT07116785 is actively recruiting participants. Contact the research team at dor.yshukrun@gmail.com for enrollment information.
Where is the NCT07116785 trial being conducted?
This trial is being conducted at Beersheba, Israel.
Who is sponsoring the NCT07116785 clinical trial?
NCT07116785 is sponsored by Ben-Gurion University of the Negev. The principal investigator is Abraham Zangen, Prof. at Ben-Gurion University of the Negev. The trial plans to enroll 50 participants.