Status:
ACTIVE_NOT_RECRUITING
Development of Adaptive Deep Brain Stimulation for OCD
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of Pittsburgh
Brown University
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and dis...
Detailed Description
ENROLLMENT: A subject is considered enrolled upon signing informed consent, deemed eligible to be screened by the investigator. The informed consent process may include discussions with the patient¿s ...
Eligibility Criteria
Inclusion
- OCD DBS Subject Inclusion criteria:
- Signed informed consent prior to any study specific procedures being performed
- Male or female between ages 21 and 70;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Y-BOCS minimum score of 28;
- Failed an adequate trial of at least three of the following SSRIs:
- Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
- Failed an adequate trial of clomipramine;
- Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
- Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- Stable psychotropic medical regimen for the month preceding surgery
- Non-Implanted Control Subject Inclusion criteria:
- Signed informed consent prior to any study specific procedures being performed
- Male or female between ages 21 and 70
Exclusion
- OCD DBS Subject Exclusion criteria:
- Inability or refusal to give informed consent.
- Lifetime diagnosis of psychotic disorders such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
- Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
- Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
- Need for Diathermy
- Contraindications to MRI
- Non-Implanted Control Subject Exclusion criteria:
- Inability or refusal to give informed consent.
- Lifetime diagnosis of mental illness
- A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
- 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
- Pregnant (confirmed by self-report for females of child bearing age)
- Contraindications to MRI
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04281134
Start Date
October 11 2019
End Date
June 1 2026
Last Update
April 17 2025
Active Locations (3)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
2
Brown University
Providence, Rhode Island, United States, 02912
3
Baylor College of Medicine
Houston, Texas, United States, 77030