Using rTMS to help patients with OCD who don't respond to therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Odile A van den Heuvel, MD PhD
• Email: oa.vandenheuvel@amsterdamumc.nl
• Phone: +31-20-4444444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.