Accelerated rTMS in Hospitalized Patients With OCD: a Feasibility and Mechanistic Study
Recruiting · NCT07135414 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Ghent
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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.
Where it is running
1 location listed.
- UZ Gent - Ghent, Oost-Vlaanderen, Belgium