TMS for Exposure Therapy Resistant OCD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- repetitive transcranial magnetic stimulation (rTMS)
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
GGZ inGeest
Collaborator
Radboud University Medical Center
Collaborator
ProPersona
Collaborator
Maastricht University Medical Center
Collaborator
Mondriaan
Collaborator
Neurocare
Collaborator
Source ClinicalTrials.gov