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TMS for Exposure Therapy Resistant OCD

Study acronym: TETRO
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Apr 1, 2026 to Dec 1, 2027
    • Primary endpoint revised
    • Study completion date: Sep 1, 2027 to Dec 1, 2027
    • Study description expanded, about 273 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 8
    • Start date changed from estimate of May 1, 2022 to May 16, 2022
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05331937
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: GGZ inGeest, Radboud University Medical Center, ProPersona, Maastricht University Medical Center, Mondriaan, Neurocare
Conditions
(from sponsor)		 1 Hz Real rTMS to the Pre-SMA, 1 Hz Sham rTMS to the Pre-SMA
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov