Accelerated Rotational Field Deep TMS for Treating OCD

Official title

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

Overview

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.

Interventions

• 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 disorder
• 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.

Primary outcome measures

• Yale Brown Obsessive Compulsive Scale (YBOCS) [Time frame: 6 weeks]

Secondary outcome measures (1)

• Yale Brown Obsessive Compulsive Scale (YBOCS) [Time frame: 13 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Soroka University Medical Center — Beersheba

Identifiers

NCT: NCT07116785 · 0140-22-SOR · 0140-22-SOR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗