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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT04806516
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent prior to any study specific procedures being performed
2. Male or female between ages 21 and 70;
3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
4. A primary diagnosis of OCD with Y-BOCS minimum score of 28;
5. Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
6. Failed or could not tolerate an adequate trial of clomipramine;
7. Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
8. Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
9. Stable psychotropic medical regimen for the month preceding surgery
Exclusion Criteria:
1. Inability or refusal to give informed consent.
2. Lifetime diagnosis of psychotic disorders such as schizophrenia;
3. Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
4. Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
5. Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
6. Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
7. Need for Diathermy
8. Contraindications to MRI
9. Contraindications to MEG
10. Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04806516
Study Brief:
Protocol Section:
NCT04806516