Using rTMS to help patients with OCD who don't respond to therapy
Transcranial Magnetic Stimulation (TMS) for Patients With Exposure Therapy-resistant Obsessive-compulsive Disorder (OCD): TETRO - a Multicenter Randomized Controlled Trial
This study is testing if a new brain treatment called rTMS can help adults with OCD who haven't improved with regular therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 8 sites (Amsterdam, North Holland and 7 other locations) |
| Trial ID | NCT05331937 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the pre-supplementary motor area (pre-SMA) as an additional treatment for adults with obsessive-compulsive disorder (OCD) who have not responded adequately to exposure therapy with response prevention (ERP). The trial involves a multi-center, placebo-controlled, double-blind design, with participants receiving rTMS four times a week for 5-7 weeks, combined with ERP. The study aims to assess both the clinical and cost-effectiveness of this approach over a follow-up period of 12 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of OCD and insufficient response to previous ERP treatments.
Not a fit: Patients who have not been diagnosed with OCD or those who have not tried ERP may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with OCD who have not benefited from standard therapies.
How similar studies have performed: Previous studies have shown promising results for rTMS in treating OCD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Amsterdam, North Holland and 7 other locations
- Amsterdam UMC, location VU Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)
- GGZ inGeest — Amsterdam, Netherlands (Recruiting)
- Neurocare — Eindhoven, Netherlands (Not_yet_recruiting)
- Neurocare — Groningen, Netherlands (Not_yet_recruiting)
- Maastricht UMC+ — Maastricht, Netherlands (Not_yet_recruiting)
- Mondriaan — Maastricht, Netherlands (Not_yet_recruiting)
- ProPersona — Nijmegen, Netherlands (Not_yet_recruiting)
- Radboudumc — Nijmegen, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Odile A van den Heuvel, MD PhD
- Email: oa.vandenheuvel@amsterdamumc.nl
- Phone: +31-20-4444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.