Actively Recruiting
Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
Led by Baylor College of Medicine · Updated on 2025-05-14
10
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability. We will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab/clinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms. Subjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2). At home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.
CONDITIONS
Official 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 OCD per DSM-5
- Adults aged 18 to 64 years
- At least five years of treatment-resistant OCD causing significant distress and impaired function
- Minimum score of 28 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
- Failed adequate trials of at least three SSRIs
- Failed an adequate trial of clomipramine
- Failed augmentation with at least one antipsychotic medication
- Failed adequate cognitive behavioral therapy with at least 25 hours of exposure and response prevention by an expert
- Stable psychotropic medication for at least one month before surgery
- Approved by a multi-disciplinary team for DBS surgery within two months of enrollment
- Ability to provide informed written consent
- Availability of a family member or significant other to accompany to study visits if needed
You will not qualify if you...
- Lifetime diagnosis of psychotic disorder such as schizophrenia
- Alcohol or substance abuse or dependence within the past 6 months, excluding nicotine
- High risk of suicidal behavior or impulsivity
- Pregnancy or plans to become pregnant in the next 24 months
- Need for diathermy
- Any neurological or medical condition making the participant a poor candidate for study procedures
- Comorbid psychiatric disorders interfering with study participation
- Primary diagnosis of Hoarding Disorder
AI-Screening
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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
CONTACT
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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