RecruitingNot ApplicableNCT07135414

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


Sponsor

University Hospital, Ghent

Enrollment

60 participants

Start Date

May 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated form of repetitive transcranial magnetic stimulation (rTMS) — a non-invasive brain stimulation technique — in people who are hospitalized for severe obsessive-compulsive disorder (OCD) and also undergoing Exposure and Response Prevention (ERP) therapy. The goal is to see if this adds to the benefits of standard intensive therapy. **You may be eligible if...** - You are 18–65 years old - You are currently hospitalized specifically for OCD - You are participating in Exposure and Response Prevention Therapy (ERP) as part of your treatment - Your OCD symptoms are moderate to severe (Y-BOCS score of 20 or higher) **You may NOT be eligible if...** - You are experiencing active suicidal thoughts or behaviors - You have an active psychotic disorder - You have a current substance use disorder - You have a metal implant in your head (such as a cochlear implant or deep brain stimulator), as rTMS uses a magnetic field - You have epilepsy or a history of seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREiTBS

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.

PROCEDUREdTMS

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.

BEHAVIORALERP

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

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NCT07135414


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