TMS for Exposure Therapy Resistant OCD
NCT05331937 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-03-04
Summary
TETRO is a multi-center placebo-controlled double-blind randomized controlled trial with an intervention phase of 5-7 weeks and a follow-up phase of 12 months in 250 adult (18 years and older) OCD patients who show no/insufficient response to ERP, aiming to establish the cost-effectiveness of low frequency (1 Hz) rTMS to the pre-SMA (compared to sham rTMS to the pre-SMA) as adjuvant treatment to exposure with response prevention (ERP). The treatment consists of 4 times/week rTMS combined with ERP for at least 5 weeks (20 sessions), with optional extension phase of 1 or 2 weeks (maximum of 28 sessions in total).
Conditions
- 1 Hz Real rTMS to the Pre-SMA
- 1 Hz Sham rTMS to the Pre-SMA
Interventions
- COMBINATION_PRODUCT
-
repetitive transcranial magnetic stimulation (rTMS)
rTMS (real versus sham) is used as adjuvant to ERP
Sponsors & Collaborators
-
GGZ inGeest
collaborator OTHER -
Radboud University Medical Center
collaborator OTHER -
ProPersona
collaborator OTHER -
Maastricht University Medical Center
collaborator OTHER -
Mondriaan
collaborator UNKNOWN -
Neurocare
collaborator OTHER -
Amsterdam UMC, location VUmc
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-16
- Primary Completion
- 2027-12-01
- Completion
- 2027-12-01
Countries
- Netherlands
Study Locations
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