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Obsessive-Compulsive Disorder (OCD)NCT05422469

Neurobehavioral Investigations of Approach Dynamics in the Ventral Striatum

A study testing Medtronic Percept RC neurostimulator in people with Obsessive-Compulsive Disorder (OCD), run by Baylor College of Medicine at 2 sites in United States.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Traditional strategies for diagnosing psychiatric disorders focus on definitions based on constellations of co-occurring symptoms. Tracking symptom severity across therapy arcs relies on administering scales that again ask questions about symptoms. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obsessive-Compulsive Disorder (OCD)
What is being tested?
Medtronic Percept RC neurostimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
Aug 2027to Aug 2029
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Planned for DBS for OCD (via clinical pathway, FDA HDE, IRB) or BD (via BRAIN-funded UH3 trial)
  • Agrees to study activities in NBU and "home" environments

Who cannot join

  • Planned to receive non-rechargeable DBS generator

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sameer Sheth, MD, PhD contact

713-798-5060

sameer.sheth@bcm.edu

United States2 sites
  • Baylor College of Medicine

    Houston, Texas, 77030

    Sameer Sheth, MD, PhD, 713-798-5060, sameer.sheth@bcm.edu

  • Brown University

    Providence, Rhode Island, 02912

    Wael Asaad, wael_asaad@brown.edu

Other trials in United States

About this study

Traditional strategies for diagnosing psychiatric disorders focus on definitions based on constellations of co-occurring symptoms. Tracking symptom severity across therapy arcs relies on administering scales that again ask questions about symptoms. These strategies have allowed some degree of standardization but suffer from having a phenomenological rather than mechanistic foundation (in terms of diagnosis) as well as subjectivity and temporal sparseness (in terms of measurement).

The investigators apply a transdiagnostic framework based on the neurobiological concept of approach behavior. Several psychiatric disorders (including OCD, uni- and bipolar depression, PTSD and anxiety disorders, and addiction disorders) are characterized by dysfunction in approach behavior. The investigators study the neurobehavioral basis of approach dysfunction in a cohort of individuals with severe OCD and bipolar disorder (BD). To study these behaviors, the investigators deploy a suite of wearables and peripherals (Oura ring, Apple Watch, iPhone, audioband) that allow continuous and dense measurement of behaviors relevant to the approach hypothesis: socialization, activity, and sleep patterns. The investigators perform these measurements in two selected environments. One is a novel apartment-style setting (neurobehavioral unit, NBU) that combines the high-bandwidth data acquisition capability of a lab with the naturalistic relevance and comfort of the home. The second is the truly natural and maximally ethologically relevant setting of the ambulatory "home" environment in which people spend the majority of their time.

Read more

The participants will be individuals planned for deep brain stimulation (DBS) implant for their OCD or BD. The bi-directional (stimulate as well as record) nature of the DBS systems will allow neural recordings that the investigators will synchronize with the behavioral data streams. The investigators will apply predictive computational models in conjunction with the causal manipulation provided by stimulation to test mechanistic hypothesis relating neurophysiology, behavior, and clinical status. In Aim 1, The investigators study reward-driven decision making by employing an augmented reality approach-avoidance task in the NBU. In Aim 2, the investigators test the neurobehavioral models' ability to predict clinical status from passively (and therefore low burden to patient-participants) acquired data in the "home" environment. In Aim 3, the investigators identify neural predictors of the patterns of sleep dysregulation associated with these disorders using the unique environment of the NBU. In Aim 4, the investigators examine critical concepts of ethics and ethology that arise with this new field of naturalistic, chronic brain-behavior relationship investigation.

The investigators hope that methods validated and lessons learned in this project will improve understanding of the mechanistic basis of a range of psychiatric disorders and thereby allow greater rational design of therapeutic delivery.

Read the detailed description

Traditional strategies for diagnosing psychiatric disorders focus on definitions based on constellations of co-occurring symptoms. Tracking symptom severity across therapy arcs relies on administering scales that again ask questions about symptoms. These strategies have allowed some degree of standardization but suffer from having a phenomenological rather than mechanistic foundation (in terms of diagnosis) as well as subjectivity and temporal sparseness (in terms of measurement).

The investigators apply a transdiagnostic framework based on the neurobiological concept of approach behavior. Several psychiatric disorders (including OCD, uni- and bipolar depression, PTSD and anxiety disorders, and addiction disorders) are characterized by dysfunction in approach behavior. The investigators study the neurobehavioral basis of approach dysfunction in a cohort of individuals with severe OCD and bipolar disorder (BD). To study these behaviors, the investigators deploy a suite of wearables and peripherals (Oura ring, Apple Watch, iPhone, audioband) that allow continuous and dense measurement of behaviors relevant to the approach hypothesis: socialization, activity, and sleep patterns. The investigators perform these measurements in two selected environments. One is a novel apartment-style setting (neurobehavioral unit, NBU) that combines the high-bandwidth data acquisition capability of a lab with the naturalistic relevance and comfort of the home. The second is the truly natural and maximally ethologically relevant setting of the ambulatory "home" environment in which people spend the majority of their time.

The participants will be individuals planned for deep brain stimulation (DBS) implant for their OCD or BD. The bi-directional (stimulate as well as record) nature of the DBS systems will allow neural recordings that the investigators will synchronize with the behavioral data streams. The investigators will apply predictive computational models in conjunction with the causal manipulation provided by stimulation to test mechanistic hypothesis relating neurophysiology, behavior, and clinical status. In Aim 1, The investigators study reward-driven decision making by employing an augmented reality approach-avoidance task in the NBU. In Aim 2, the investigators test the neurobehavioral models' ability to predict clinical status from passively (and therefore low burden to patient-participants) acquired data in the "home" environment. In Aim 3, the investigators identify neural predictors of the patterns of sleep dysregulation associated with these disorders using the unique environment of the NBU. In Aim 4, the investigators examine critical concepts of ethics and ethology that arise with this new field of naturalistic, chronic brain-behavior relationship investigation.

The investigators hope that methods validated and lessons learned in this project will improve understanding of the mechanistic basis of a range of psychiatric disorders and thereby allow greater rational design of therapeutic delivery.

Being tested
Medtronic Percept RC neurostimulator
Keywords
Deep Brain Stimulation (DBS), Treatment Resistant OCD, Intractable OCD
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Percept RC neurostimulatorDevice

    Medtronic SenSight directional DBS leads and implanted pulse generators (IPGs) will be implanted

Study groups in NCT05422469
Study groupRoleWhat they receive
Medtronic Percept RC neurostimulatorExperimentalNot described
Receives: Device: Medtronic Percept RC neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score

    Severity of depression symptoms. Changes in the Yale-Brown Obsessive Compulsive Scale survey/questionnaire. YBOCS is an assessment to rate symptoms of OCD on a scale of 0-50 (with a higher number indicating a more severe outcome ratings of OCD and 0 indicated no symptoms of OCD).

    Measured: Through study completion, an average of 14 months

  2. Change in Hamilton Depression Inventory (HAM-D) Score

    Severity of depression symptoms. Changes in the Hamilton Depression Inventory (HAM-D) score. HAM-D is an assessment to rate symptoms of depression on a scale of 0-52 (with a higher number indicating a more severe outcome ratings of depression and 0 indicated no symptoms of depression).

    Measured: Through study completion, an average of 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study startAug 2027 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422469
Sponsor's protocol ID
56119
Status last verified
Sep 2026
First submitted
27 May 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

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