RECRUITINGINTERVENTIONAL

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

Accelerated Repetitive Transcranial Magnetic Stimulation in Hospitalized Patients With Obsessive-Compulsive Disorder: a Feasibility and Mechanistic RCT

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

iTBS

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.

PROCEDURE

dTMS

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.

BEHAVIORAL

ERP

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.

Locations (1)

UZ Gent

Ghent, Oost-Vlaanderen, Belgium