Accelerated rTMS in Hospitalized Patients With OCD: a Feasibility and Mechanistic Study

Not Applicable

Recruiting

• Conditions: Obsessive - Compulsive Disorder

• Registration Number: NCT07135414
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

This study aims to explore the combination of specialized inpatient care for Obsessive-Compulsive Disorder (OCD) with treatment using repetitive Transcranial Magnetic Stimulation (rTMS) in patients diagnosed with OCD. Specifically, the investigators seek to assess the feasibility, desirability, and tolerability of this combined approach, as well as its clinical and neural effects.

The study protocol consists of three arms. All arms include Exposure and Response Prevention (ERP), an established psychotherapeutic treatment for OCD. Two arms will investigate two different types of rTMS: conventional deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both rTMS treatments will be administered using an accelerated protocol, involving four sessions per day. The third arm consists of ERP without any form of neuromodulation (i.e., treatment-as-usual).

Study Design:

This is a randomized clinical trial (RCT) evaluating the feasibility, efficacy, safety, and suitability of the two types of accelerated rTMS protocols, in addition to ERP therapy in patients with OCD. The study also aims to investigate the neural mechanisms underlying these treatment approaches.

Patients will be randomly assigned by a computer program to one of three treatment groups. All groups will receive ERP. Two groups will receive either iTBS or dTMS combined with ERP, and the third group will receive ERP without rTMS.

Participant Requirements:

Questionnaires: Completion of surveys before treatment, immediately after treatment, and four weeks post-treatment.

MRI \& EEG: Undergo functional and structural brain imaging (MRI) and high-definition electroencephalography (hdEEG) before and after the treatment period.

Adverse Effects Diary: Maintain a daily log of any side effects experienced during the treatment period.

Study Duration:

The total expected duration of participation is ten weeks. Magnetic stimulation treatment will take place over two weeks, within a standard hospitalization of twelve weeks in an OCD inpatient department. Participation does not require additional hospital visits compared to usual treatment.

Study Location:

The study will be conducted at UZ Gent, Building K12F, Corneel Heymanslaan 10, 9000 Ghent, Belgium. A total of 60 patients will participate, with 40 patients receiving rTMS treatment. All procedures will take place within Belgium.

Participant Involvement:

During the twelve-week hospitalization, rTMS treatment will commence approximately two weeks after admission. The initial two-week period allows for familiarization with the department and ERP therapy. Prior to inclusion, eligibility will be assessed through a 60-minute consultation, a semi-structured diagnostic interview (MINI-5), and a structured assessment of OCD symptoms (Y-BOCS symptom checklist) to identify any exclusion criteria or contraindications.

Eligible patients will undergo two brain imaging procedures: functional and structural MRI and hdEEG. Additionally, five questionnaires will be administered collectively.

The rTMS protocol will then be implemented over a two-week period, with four sessions per day, four days per week, totaling 32 sessions. During this period, patients will complete a daily adverse effects questionnaire. Immediately after treatment, post-treatment assessments will include questionnaires and repeated fMRI and hdEEG scans. Four weeks later, follow-up questionnaires assessing OCD symptoms and related measures will be completed.

Certain visits and procedures described in the study will be part of standard care at the hospital, while others are specific to the research protocol. Throughout the twelve-week hospitalization, all groups will receive standard care, including medication optimization and evidence-based psychotherapeutic interventions for OCD. rTMS will be offered as an adjunctive treatment to this standard care.

Study Timeline

• Study Start: 2025-05-25
• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-Reported Severity of Adverse Effects [Safety]	From start to end of rTMS treatment period (2 weeks)	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]	From start to end of rTMS treatment period (2 weeks)	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]	From enrollment to end of treatment (approximately 2 weeks of rTMS)	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

Secondary Outcome Measures

Name	Time	Method
Functional MRI-Based Resting-State Functional Connectivity	Before and after each treatment arm (2 weeks).	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	Before and after each treatment arm (2 weeks).	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	Before and after each treatment arm (2 weeks).	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	Before and after each treatment arm (2 weeks).	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.
EEG-Based Resting-State Oscillatory Power	Before and after each treatment arm (2 weeks).	High-definition EEG will be used to quantify resting-state oscillatory activity in standard frequency bands (delta, theta, alpha, beta, gamma). Unit of Measure: Change in spectral power per frequency band and region.
EEG-Based Resting-State Functional Connectivity	Before and after each treatment arm (2 weeks).	Functional connectivity will be assessed using phase- and coherence-based metrics to evaluate connectivity between cortical regions of interest. Unit of Measure: Change in connectivity strength.

Trial Locations

Locations (1)

UZ Gent; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium