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RECRUITINGPhase 3INTERVENTIONAL

TMS for Exposure Therapy Resistant OCD

Transcranial Magnetic Stimulation (TMS) for Patients With Exposure Therapy-resistant Obsessive-compulsive Disorder (OCD): TETRO - a Multicenter Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

COMBINATION_PRODUCT

repetitive transcranial magnetic stimulation (rTMS)

rTMS (real versus sham) is used as adjuvant to ERP

Locations (8)

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