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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04281134
Eligibility Criteria:
Inclusion Criteria:
* OCD DBS Subject 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. 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 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
Non-Implanted Control Subject Inclusion criteria:
1. Signed informed consent prior to any study specific procedures being performed
2. Male or female between ages 21 and 70
Exclusion Criteria:
* OCD DBS Subject 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
Non-Implanted Control Subject Exclusion criteria:
1. Inability or refusal to give informed consent.
2. Lifetime diagnosis of mental illness
3. A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
4. Any neurological disorders (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
5. Pregnant (confirmed by self-report for females of child bearing age)
6. Contraindications to MRI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT04281134
Study Brief:
Protocol Section:
NCT04281134