Actively Recruiting
Neurophysiological Investigation of the Approach-avoidance Axis in OCD Using Deep Brain Stimulation and Neuromodulation
Led by Baylor College of Medicine · Updated on 2025-05-14
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating obsessive compulsive disorder (OCD) in adults who have not responded to standard treatments. This study focuses on understanding the brain's approach-avoidance mechanisms by using deep brain stimulation (DBS) combined with detailed neurobehavioral data collection. The study aims to explore neural activity in both controlled clinical settings and natural home environments to identify patterns linked to decision-making and symptom improvement. Participants will receive permanent DBS leads implanted along with a rechargeable device capable of recording brain activity. The study involves multiple assessments at seven key timepoints: before implant, just before and immediately after DBS activation, then at 2 weeks, 3 months, 6 months, and 12 months post-activation. Data will be gathered during specific behavioral tasks and therapeutic exposure trials in the clinic, plus continuous neural recordings paired with wearable devices and video diaries at home. Throughout the study, participants will undergo clinical assessments, complete behavioral tests, and engage in psychological guidance sessions. The research team will monitor changes in OCD symptoms over 14 months, using neural and behavioral measures collected in both clinic and home settings. This comprehensive approach aims to track clinical status and inform future treatment decisions, with involvement lasting at least one year after DBS initiation.
CONDITIONS
Brief Title
Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Principal diagnosis of obsessive compulsive disorder (OCD) according to DSM-5
- Adults aged between 18 and 64 years
- At least five years of treatment-resistant OCD causing significant distress and impaired functioning
- Minimum score of 28 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
- Failure of adequate trials with at least three selective serotonin reuptake inhibitors (SSRIs)
- Failure of an adequate trial of clomipramine
- Failure of augmentation with at least one antipsychotic medication
- Completion of at least 25 hours of cognitive behavioral therapy with exposure and response prevention
- Stable psychotropic medication for at least one month before surgery
- Approval by a multidisciplinary team to undergo deep brain stimulation (DBS) surgery within two months of enrollment
- Ability to provide informed written consent
- Availability of a family member or significant other to accompany the patient to study visits if needed
You will not qualify if you...
- Lifetime diagnosis of psychotic disorders such as schizophrenia
- Alcohol or substance abuse or dependence within the past six months, excluding nicotine
- High risk of suicidal behavior or impulsivity
- Pregnant or planning pregnancy within the next 24 months
- Need for diathermy treatment
- Any neurological or medical condition making participation unsafe, as judged by the study team
- Comorbid psychiatric disorders that may interfere with participation
- Primary diagnosis of hoarding disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 months post-surgery including immediate care
Participants undergo deep brain stimulation (DBS) surgery as part of the study intervention.
1 surgery visit and multiple follow-up visits
Duration - 14 months
Participants are monitored for changes in OCD symptoms over 14 months following the intervention.
Regular visits over 14 months
Trial Site Locations
Total: 2 locations
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicole Provenza, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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