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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
UZ Gent
RECRUITING
Ghent
Contact Information
Primary
Stefanie De Smet, PhD
stefanie.desmet@ugent.be
00329 332 43 94
Backup
Chris Baeken, PhD. MD. Psychiatry
chris.baeken@uzgent.be
00329 332 43 94
Time Frame
Start Date: 2025-05-25
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 60
Treatments
Experimental: dTMS + ERP
20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.
Experimental: iTBS + ERP
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.
Active_comparator: Control (ERP)
20 hospitalized patiënts who will receive psychofarmacological treatment and exposure responseprevention for OCD. No TMS.
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov