Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT06942559
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06942559
Study Brief:
Protocol Section:
NCT06942559