NCT05331937 TMS for Exposure Therapy Resistant OCD
| NCT ID | NCT05331937 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | 1 Hz Real rTMS to the Pre-SMA |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-05-16 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2022-05-16 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05331937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying 1 Hz Real rTMS to the Pre-SMA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05331937 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT05331937 currently recruiting?
Yes, NCT05331937 is actively recruiting participants. Contact the research team at oa.vandenheuvel@amsterdamumc.nl for enrollment information.
Where is the NCT05331937 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amsterdam, Netherlands, Eindhoven, Netherlands, Groningen, Netherlands and 4 additional locations.
Who is sponsoring the NCT05331937 clinical trial?
NCT05331937 is sponsored by Amsterdam UMC, location VUmc. The trial plans to enroll 250 participants.