TMS for Exposure Therapy Resistant OCD

Launched by AMSTERDAM UMC, LOCATION VUMC · Apr 15, 2022

Keywords

ClinConnect Summary

The TETRO trial is studying a new treatment for adults with obsessive-compulsive disorder (OCD) who have not responded well to standard therapy called exposure therapy with response prevention (ERP). This trial will involve approximately 250 participants who will receive either active treatment using a method called repetitive transcranial magnetic stimulation (rTMS) or a placebo treatment (which is like a "fake" treatment that doesn’t have real effects). The goal is to see if the rTMS treatment, given four times a week for about 5 to 7 weeks, can help improve their symptoms over the long term.

To be eligible for the trial, participants must be at least 18 years old, have a current diagnosis of OCD, and score at least 16 on a specific OCD symptom scale. They should also have not responded well to previous ERP treatment. Participants will need to commit to attending treatment sessions four days a week and may have some other mental health conditions as long as OCD is their main issue. It's important to know that those with certain conditions, like severe depression or other psychiatric disorders, cannot participate. Throughout the trial, participants will be closely monitored, and they will also have to complete an MRI scan before starting treatment. This trial is currently recruiting, so if you think you or someone you know might be eligible, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

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)