Investigating brain activity in patients with OCD using deep brain stimulation

Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation

This study is testing how deep brain stimulation can help people with severe OCD by looking at their brain activity and behaviors in different settings.

Quick facts

• Study type: Observational
• Enrollment: 10 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06596447 on ClinicalTrials.gov

What this trial studies

This observational study aims to recruit 10 patients diagnosed with treatment-refractory Obsessive Compulsive Disorder (OCD) for surgical evaluation and implantation of deep brain stimulation (DBS) devices. Participants will undergo extensive neurobehavioral assessments in both clinical and home settings to analyze neural activity patterns related to approach and avoidance behaviors. The study will utilize on-device neural recordings and behavioral measures to explore the underlying neural mechanisms of OCD symptoms across different environments. The research seeks to enhance understanding of OCD and the potential applications of neuromodulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 64 with a principal diagnosis of OCD that has not improved despite multiple treatment attempts.

Not a fit: Patients who have not met the criteria for treatment-refractory OCD or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe OCD who have not responded to conventional therapies.

How similar studies have performed: While there have been studies on deep brain stimulation for OCD, this specific approach combining neurophysiological investigation with neuromodulation is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Principal diagnosis of OCD per DSM-5;
2. Adult between ages 18 and 64;
3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
4. Minimum score of 28 on the Y-BOCS;
5. Failed an adequate trial of at least three SSRIs;
6. Failed an adequate trial of clomipramine;
7. Failed augmentation of one or more of the aforementioned drugs with at least one anti-psychotic medication;
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;
10. Principal diagnosis of OCD who are approved by our multi-disciplinary team to undergo DBS surgery within two months of enrollment;
11. Ability to provide fully informed, written consent;
12. Availability of a family member or significant other who is willing to accompany patients to study visits if necessary.

Exclusion Criteria:

1. Lifetime diagnosis of psychotic disorder such as schizophrenia;
2. Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
3. Concern for high risk of suicidal behavior or impulsivity;
4. Patient is \[regnant or plans to become pregnant in the next 24 months;
5. Need for diathermy;
6. 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
7. Comorbid psychiatric disorder that, in the opinion of the study team, may interfere with the candidate's ability to participate in study activities;
8. Primary diagnosis of a Hoarding Disorder.

Where this trial is running

Houston, Texas and 1 other locations

• Baylor College of Medicine — Houston, Texas, United States (NOT_YET_RECRUITING)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Nicole Provenza, PhD

Conditions: Obsessive Compulsive Disorder, Neuromodulation, OCD, Deep Brain Stimulation, DBS