This study investigates a new treatment approach for Obsessive-Compulsive Disorder (OCD), a condition characterized by unwanted repetitive thoughts and behaviors. The goal is to determine whether combining specialized inpatient care with repetitive Transcranial Magnetic Stimulation (rTMS) is feasible, well-tolerated, and effective. rTMS is a non-invasive procedure that uses magnetic pulses to stimulate specific areas of the brain. In this study, two types of rTMS will be tested: deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both treatments will be administered using an accelerated protocol, involving multiple sessions per day over a two-week period.
Patients will be randomly assigned to one of three groups: two groups will receive either dTMS or iTBS combined with Exposure and Response Prevention (ERP), a recognized psychotherapy for OCD; the third group will receive only ERP without rTMS.
Participant Requirements next to treatment:
Questionnaires: Patients will complete surveys before the treatment period, immediately after the treatment period, and four weeks post-treatment.
MRI \& EEG: Patients will undergo brain imaging (MRI) and brain wave (EEG) recordings before and after the treatment period.
Adverse Effects Diary: Patients will maintain a daily log of any side effects experienced during the treatment period.
The study aims to assess the feasibility, safety, and effectiveness of this combined treatment approach and to examine its effects on underlying brain processes related to clinical outcomes.
Age between 18 and 65
Hospitalization for Obsessive-Compulsive Disorder (OCD)
Participation in Exposure and Response Prevention Therapy
Significant OCD, as measured by a Y-BOCS score of 20 or higher (moderate to severe OCD symptoms)
Acute suicidality: Individuals presenting with current suicidal ideation or behavior are excluded to ensure participant safety.
Psychotic disorder: patients with active psychotic disorders are excluded due to the complexity of their condition and potential interactions with the study protocol.
Current substance use disorder: active substance use disorders are exclusionary to prevent confounding effects on study outcomes.
Deep Brain Stimulation (DBS) for OCD: participants with an implanted DBS device for OCD are excluded due to potential interference with the study's interventions and safety concerns.
Parallel
iTBS
Procedure/SurgeryIntermittent theta burst stimulation (iTBS) targeting the left Dorsolateral Prefrontal Cortex (LDLPFC) will be delivered using a figure-of-eight coil at 50 Hz (3 pulses per burst, 5 Hz burst frequency), with 10 bursts over 2 seconds, followed by an 8-second pause, resulting in a 10-second cycle duration, repeated 60 times for a total of 1800 pulses.
dTMS
Procedure/SurgeryDeep TMS (dTMS) targeting the medial prefrontal cortex (MPFC) will be delivered using an H7 coil at 20 Hz for 2 seconds per cycle, followed by a 20-second pause, resulting in a 22-second cycle duration, repeated 50 times for a total of 2000 pulses.
ERP
BehavioralPatients are admitted to a residential program that includes nonverbal therapies, cognitive behavioural therapy, and from week 3 onward, weekly Exposure Relapse Prevention (ERP) sessions (3 hours/week for 8 weeks; total admission = 10 weeks). ERP includes an inventory of OCD symptoms, psychoeducation on the difference between obsessions and compulsions using an OCD model, and the creation of a stepwise fear hierarchy with exposure and response prevention exercises. Patients practice both during and outside sessions, including at home on weekends. Family involvement is integrated: relatives are invited every three weeks to receive psychoeducation on OCD and ERP, are informed about accommodation behaviors, and may attend a session.
Self-Reported Severity of Adverse Effects [Safety]
Severity of specific adverse effects (e.g., headache, tooth pain, scalp discomfort, fatigue, etc.) will be assessed daily using a visual analogue scale (VAS) ranging from 0 (not at all) to 10 (extremely severe). Scores will be collected daily for the duration of the treatment. Unit of Measure: VAS score (0-10) per adverse effect
Incidence of Any Self-Reported Adverse Effect [Safety]
Occurrence of any self-reported adverse effect (i.e., VAS \> 0 for any symptom) during the rTMS treatment period. Unit of Measure: Number of participants reporting ≥1 adverse effect
Participant Retention Rate [Feasibility]
Percentage of participants who complete the full rTMS treatment protocol (32 sessions over 2 weeks) out of those who consented and were randomized. Unit of Measure: Percentage of participants completing protocol
Functional MRI-Based Resting-State Functional Connectivity
Resting-state functional MRI (rs-fMRI) will be used to assess changes in intrinsic brain network connectivity. Whole-brain and region-of-interest (ROI) connectivity analyses will be performed. Unit of Measure: Change in functional connectivity (Fisher z-scores or correlation coefficients) between selected brain regions
Structural MRI-Based Grey Matter Volume
Structural MRI scans will be used to estimate grey matter volume in regions implicated in OCD and rTMS target. Voxel-based morphometry and region-specific volumetric analyses will be performed. Unit of Measure: Change in grey matter volume in specified regions
DTI-Based White Matter Microstructure
Diffusion Tensor Imaging (DTI) will be used to assess white matter integrity through metrics such as fractional anisotropy (FA) and mean diffusivity (MD). Analyses will focus on tracts implicated in OCD and rTMS targets. Unit of Measure: Change in DTI metric values in specified white matter tracts.
ASL-Based Resting Cerebral Blood Flow
Arterial Spin Labeling (ASL) MRI will be used to quantify resting-state cerebral blood flow (CBF) in regions relevant to OCD pathophysiology and rTMS target. Region-of-interest and whole-brain voxelwise analyses will be performed. Unit of Measure: Change in CBF in specified brain regions.
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University Hospital, Ghent
Lead sponsor
University Ghent
Collaborator
