TMS for Exposure Therapy Resistant OCD

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: 1 Hz Real rTMS to the Pre-SMA, 1 Hz Sham rTMS to the Pre-SMA

In brief

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).

Key facts

Study ID

NCT05331937

Run by

Amsterdam UMC, location VUmc

People needed

250

Starts

2022-05-16

Expected to finish

2027-12-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• OCD as current primary diagnosis
• Age 18 and older
• Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 16 or higher.
• Insufficient response to state-of-the art exposure therapy with response prevention (ERP) and/or drop-out from ERP due to extreme anxiety/avoidance
• The following comorbid disorders are allowed (as long as OCD is the current primary diagnosis): depression, other anxiety disorders, ADHD, tic/Tourette's disorder, eating disorders, personality disorders, autism spectrum disorder (when this does not dominate the clinical profile, i.e. is not main diagnosis).
• Commitment to actively undergo intensive exposure therapy (both supervised during ERP sessions, as well as unsupervised at home)
• Unmedicated (for at least 8 weeks) or stable dosage of psychotropic medication (for at least 8 weeks), involving serotonergic antidepressants (SSRI, SNRI, clomipramine). Other psychotropic medication that is allowed (provided dosage is stably established for at least 8 weeks): methylphenidate, mood stabilizers, antipsychotic drugs
• Ability to participate in frequent treatment sessions (4 days/week, for 5 (or 6, or 7) weeks) at one of the 5 sites nearest to their home and/or work
• Ability to participate in pre-treatment MRI session (for neuronavigation) at one of the 3 academic sites nearest to their home and/or work
• Capacity for providing informed consent

You may not qualify if…

• OCD patients with hoarding as main symptom dimension
• The following comorbid disorders (current diagnosis) are not allowed: psychotic disorders, bipolar disorder, autism spectrum disorder (when this dominates the clinical profile, i.e. is diagnosed as main disorder), substance use disorder
• Active suicidal thoughts and intent to act on it
• Chronic use of benzodiazepines is not allowed
• Cochlear implant
• (History of) epilepsy
• Pregnancy
• Extreme claustrophobia or metallic objects in or on the body, preventing from participation in MRI session
• Space-occupying lesion on MRI
• Previous rTMS treatment (for blinding reasons)

Where it is running

• Amsterdam UMC, location VU Medical Center — Amsterdam, North Holland, Netherlands (enrolling)
• GGZ inGeest — Amsterdam, Netherlands (enrolling)
• Neurocare — Eindhoven, Netherlands
• Neurocare — Groningen, Netherlands
• Maastricht UMC+ — Maastricht, Netherlands
• Mondriaan — Maastricht, Netherlands
• ProPersona — Nijmegen, Netherlands
• Radboudumc — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.