Personalized brain stimulation for treating obsessive compulsive disorder

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 trial investigates the effectiveness of personalized repetitive transcranial magnetic stimulation (rTMS) triggered by electroencephalography (EEG) in treating obsessive compulsive disorder (OCD). It compares this personalized approach to a standard, non-personalized rTMS treatment applied to the dorsomedial prefrontal cortex. The study employs a randomized, single-blind design with two treatment arms, administering treatment five days a week over six weeks. Clinical outcomes will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and neurophysiological markers will be measured through EEG.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are 18-65 years old;
2. Have OCD as a primary disorder, confirmed by a MINI diagnosis of OCD;
3. Have OCD with treatment resistance as defined by failure of at least a course of cognitive-behavioural therapy or a single trial (≥4 weeks) of an SSRI;
4. Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
5. Have a Y-BOCS score ≥20;
6. Are fluent in the English language (spoken, written and reading);
7. Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
8. Must be deemed to have capacity to provide informed consent;
9. Must sign and date the informed consent form;
10. Stated willingness to comply with all study procedures.

Exclusion Criteria:

1. Have any contraindications to TMS as determined by the TASS questionnaire (18);
2. Have a history of a medical or neurological disorder that affects CNS (such as, traumatic brain injury, stroke, Parkinson);
3. Are pregnant or breast feeding. TMS is not unsafe in pregnancy and therefore we are not requiring a pregnancy test prior to entry. If patients become pregnant during the study they will not be excluded. We are not including patients who are currently aware of being pregnant as OCD can be affected during the later stages of pregnancy and therefore is a potential confound;
4. Have history of seizures;
5. Have any metal implant or dentures;
6. Have serious or unstable medical condition requiring immediate investigation or treatment (e.g. severe or recent cardiac disease);
7. Have cardiac pacemaker, cochlear implants, implanted electronic devices or non- electronic metallic implants or other contraindications for TMS;
8. Taking more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
9. Fulfill MINI criteria for Alcohol Use Disorder;
10. Have received any ablative neurological procedure (e.g., focused ultrasound).

Where it's running

• Centre for Addiction and Mental Health
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Brigitte Zrenner, MD — Centre for Addiction and Mental Health
• Study coordinator: Brigitte Zrenner, MD
• Email: brigitte.zrenner@camh.ca
• Phone: 416-535-8501

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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.