Status:
RECRUITING
Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
Lead Sponsor:
Baylor College of Medicine
Conditions:
Obsessive Compulsive Disorder (OCD)
Neuromodulation
Eligibility:
All Genders
18-64 years
Brief Summary
We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads...
Eligibility Criteria
Inclusion
- Principal diagnosis of OCD per DSM-5;
- Adult between ages 18 and 64;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Minimum score of 28 on the Y-BOCS;
- Failed an adequate trial of at least three SSRIs;
- Failed an adequate trial of clomipramine;
- Failed augmentation of one or more of the aforementioned drugs with at least one anti-psychotic medication;
- 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;
- Principal diagnosis of OCD who are approved by our multi-disciplinary team to undergo DBS surgery within two months of enrollment;
- Ability to provide fully informed, written consent;
- Availability of a family member or significant other who is willing to accompany patients to study visits if necessary.
Exclusion
- Lifetime diagnosis of psychotic disorder such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Concern for high risk of suicidal behavior or impulsivity;
- Patient is \[regnant or plans to become pregnant in the next 24 months;
- Need for diathermy;
- Existence of any neurological or medical condition/disorder that makes the individual, in the opinion of the study team, a poor candidate to participate in the intended study procedures
- Comorbid psychiatric disorder that, in the opinion of the study team, may interfere with the candidate's ability to participate in study activities;
- Primary diagnosis of a Hoarding Disorder.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06596447
Start Date
March 1 2025
End Date
March 1 2030
Last Update
May 14 2025
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Baylor College of Medicine
Houston, Texas, United States, 77030