Personalized brain stimulation for treating obsessive compulsive disorder
Brain-Oscillation Synchronized Stimulation of the DMPFC: A Single-Blind Study for Personalized Neuromodulation in OCD
This study is testing a personalized brain stimulation treatment for obsessive compulsive disorder to see if it works better than a standard version of the same treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06942559 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of treatment-resistant OCD.
Not a fit: Patients with contraindications to TMS or those with other significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with treatment-resistant OCD.
How similar studies have performed: Other studies have shown promise with rTMS in treating OCD, but the personalized EEG-triggered approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Are 18-65 years old; 2. Have OCD as a primary disorder, confirmed by a Mini-International Neuropsychiatric Interview (MINI) diagnosis of OCD, with treatment resistance defined as a failure of at least one course of cognitive-behavioural therapy or a single trial of an SSRI; 3. Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine); 4. Have a Y-BOCS score \>20; 5. Are fluent in the English language (spoken, written, reading); 6. Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening; 7. Must be deemed to have capacity to provide informed consent; 8. Must sign and date the informed consent form; 9. Stated willingness to comply with all study procedures. Exclusion Criteria: 1. Have any contraindications to TMS as determined by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS) questionnaire; 2. Have a history of a medical or neurological disorder that affects the central nervous system (e.g., traumatic brain injury, stroke, Parkinson's disease); 3. Are pregnant or breast feeding. TMS is not unsafe in pregnancy and therefore the study team is not requiring a pregnancy test prior to entry. If participants become pregnant during the study they will not be excluded. The study team is not including people 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 a history of seizures; 5. Have any metal implants or dentures; 6. Have a serious or unstable medical condition requiring immediate investigation or treatment (e.g., severe or recent cardiac disease); 7. Have a cardiac pacemaker, cochlear implants, implanted electronic devices, non-electronic metallic implants, or other contraindications for rTMS; 8. Take more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication; 9. Fulfill criteria for Alcohol Use Disorder.
Where this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.