Investigating brain activity in patients with OCD using deep brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Principal diagnosis of OCD per DSM-5;
2. Adult between ages 22 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 it's running

• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Nicole Provenza, PhD
• Email: nprovenz@bcm.edu
• Phone: 713-798-5060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.