Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07135414

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

Led by University Hospital, Ghent · Updated on 2025-08-22

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

U

University Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for adults with Obsessive-Compulsive Disorder (OCD), a condition marked by unwanted repetitive thoughts and behaviors. This study aims to determine whether combining specialized inpatient care with repetitive Transcranial Magnetic Stimulation (rTMS) is feasible, well-tolerated, and effective. Two types of rTMS will be tested: deep TMS (dTMS) and intermittent theta burst stimulation (iTBS), using an accelerated protocol over two weeks. Participants will be randomly assigned to one of three groups: one group will receive dTMS plus Exposure and Response Prevention (ERP), another will receive iTBS plus ERP, and the third will receive ERP alone without rTMS. Both rTMS treatments involve four sessions per day, four days per week, totaling 32 sessions over two weeks. ERP therapy includes cognitive behavioral techniques, psychoeducation, and exposure exercises, with family involvement. The treatment occurs during a twelve-week hospitalization. During the study, participants complete questionnaires before, immediately after, and four weeks post-treatment. Brain imaging (MRI) and brain wave recordings (EEG) are done before and after treatment. Patients keep a daily diary of any side effects during rTMS. Researchers will monitor safety, feasibility, clinical outcomes, and brain changes related to treatment. Total participation lasts about ten weeks, integrated into usual inpatient care including medication and psychotherapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Hospitalization for Obsessive-Compulsive Disorder (OCD)
  • Participation in Exposure and Response Prevention Therapy
  • Significant OCD symptoms with a Y-BOCS score of 20 or higher
Not Eligible

You will not qualify if you...

  • Current suicidal thoughts or behaviors
  • Active psychotic disorder
  • Current substance use disorder
  • Implanted Deep Brain Stimulation (DBS) device for OCD

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - Up to 2 weeks before hospital admission

Participants are screened for eligibility to participate in the trial.

1 consultation visit including diagnostic interviews

Hospitalization and Baseline Assessments

Duration - 2 weeks

Participants are admitted to the inpatient OCD program and complete baseline assessments including questionnaires, MRI, and EEG before starting treatment.

Baseline imaging and questionnaire visits within hospitalization

Treatment

Duration - 2 weeks

Participants receive standard inpatient care including Exposure and Response Prevention (ERP). Two groups additionally receive accelerated rTMS treatment (either deep TMS or intermittent theta burst stimulation) over a two-week period with four sessions per day, four days per week.

Multiple daily treatment sessions over 2 weeks plus daily adverse effect diary

Post-Treatment Assessments

Duration - A few days

Immediately after treatment, participants complete questionnaires and repeat MRI and EEG scans to assess treatment effects.

1 to 2 visits for post-treatment imaging and questionnaires

Follow-up

Duration - 4 weeks

Participants complete follow-up questionnaires assessing OCD symptoms and related measures approximately four weeks after treatment ends.

1 follow-up questionnaire visit

Trial Site Locations

Total: 1 location

1

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

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Research Team

S

Stefanie De Smet, PhD

C

Chris Baeken, PhD. MD. Psychiatry

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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