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NCT06596447 · ClinicalTrials.gov registry record
Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation
A clinical trial of Obsessive Compulsive Disorder (OCD) and Neuromodulation, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- 10
- Enrollment target
- 2
- Study locations
NCT06596447: Recruiting study of Obsessive Compulsive Disorder (OCD) and Neuromodulation, sponsored by Baylor College of Medicine.
NCT06596447 is a study of Obsessive Compulsive Disorder (OCD) and Neuromodulation that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 10 participants, below the 243-participant average among 12 other Obsessive Compulsive Disorder (OCD) trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06596447, a study of Obsessive Compulsive Disorder (OCD) and Neuromodulation, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 2
- Study locations
Study 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 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
Primary Outcome
Response will be defined as 35% decrease in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from baseline. The range is from 0 to 40 with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms, and 32-40 extreme symptoms.
Conditions Studied
Interventions
- DEVICE Deep Brain Stimulation
Study Locations (2)
Texas
- Baylor College of Medicine - Houston
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2030-03 |
What NCT06596447 shows while recruiting
NCT06596447 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 243-participant average among 12 other Obsessive Compulsive Disorder (OCD) trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Obsessive Compulsive Disorder (OCD) appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation is the first listed.
NCT06596447 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06596447 about?
NCT06596447 is a clinical study titled "Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation". 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 rechargeabili...
What is the current status of trial NCT06596447?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2025-03-01. Estimated completion is 2030-03.
What conditions does trial NCT06596447 study?
This clinical trial studies the following conditions: Obsessive Compulsive Disorder (OCD), Neuromodulation.
What interventions are being tested in trial NCT06596447?
The interventions under investigation include: Deep Brain Stimulation (DEVICE).
Who is sponsoring clinical trial NCT06596447?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06596447 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06596447's enrollment target sits among peer trials
10 11th of 12 higher than 1 of 12 other Obsessive Compulsive Disorder (OCD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obsessive Compulsive Disorder (OCD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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