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

NCT07135414 | Recruiting

• 1 other identifier: ONZ-2022-0372 AM02 dd 07-Mar-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive - Compulsive Disorder

Keywords

OCD; TMS; deep TMS; iTBS; Obsessive Compulsive Disorder; Transcranial Magnetic Stimulation; OCD-TMS; Hospitalized; Hospitalised; dTMS

Outcome Measures

Primary Outcomes (3)

• 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

  From start to end of rTMS treatment period (2 weeks)

• 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

  From start to end of rTMS treatment period (2 weeks)

• 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

  From enrollment to end of treatment (approximately 2 weeks of rTMS)

Secondary Outcomes (6)

• Functional MRI-Based Resting-State Functional Connectivity

  Before and after each treatment arm (2 weeks).

• Structural MRI-Based Grey Matter Volume

  Before and after each treatment arm (2 weeks).

• DTI-Based White Matter Microstructure

  Before and after each treatment arm (2 weeks).

• ASL-Based Resting Cerebral Blood Flow

  Before and after each treatment arm (2 weeks).

• EEG-Based Resting-State Oscillatory Power

  Before and after each treatment arm (2 weeks).

Study Arms (3)

dTMS + ERP

EXPERIMENTAL

20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.

Procedure: dTMS; Behavioral: ERP

iTBS + ERP

EXPERIMENTAL

20 hospitalized patients who will receive a specific form of repetitive transcranial magnetic stimulation: intermittent thetaburst stimulation (iTBS) with F8 coil; next to psychofarmacological treatment and exposure responseprevention for OCD.

Procedure: iTBS; Behavioral: ERP

Control (ERP)

ACTIVE COMPARATOR

20 hospitalized patiënts who will receive psychofarmacological treatment and exposure responseprevention for OCD. No TMS.

Behavioral: ERP

Interventions

iTBS PROCEDURE

Intermittent 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.

iTBS + ERP

dTMS PROCEDURE

Deep 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.

dTMS + ERP

ERP BEHAVIORAL

Patients 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.

Control (ERP); dTMS + ERP; iTBS + ERP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Chris Baeken, PhD. MD. Psychiatry

  UZ GENT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie De Smet, PhD

CONTACT

00329 332 43 94; stefanie.desmet@ugent.be

Chris Baeken, PhD. MD. Psychiatry

CONTACT

00329 332 43 94; chris.baeken@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Family and relatives of the patient also remain unaware of the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Chris Baeken

Model Details: Randomized clinical trial (RCT)

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 22, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

BE (1)