Neurobehavioral Investigations of Approach Dynamics in the Ventral Striatum
Key facts
- Who runs it
- Baylor College of Medicine
- Where
- Houston and Providence, United StatesSee the 2 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 12 people, planned
- Starts
- Aug 2027
- Expected to end
- Aug 2029
- Type of study
- Interventional
- Treatments tested
- Medtronic Percept RC neurostimulator
- Record updated
- 1 October 2026
Who can take part
- Age
- 18 years to 64 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- Planned to receive non-rechargeable DBS generator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in United States
- Baylor College of MedicineHouston, United StatesContact: Sameer Sheth, MD, PhDNot yet recruiting
- Brown UniversityProvidence, United StatesContact: Wael AsaadNot yet recruiting
About the trial
What the trial wants to find out
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).
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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.
The group in the trial
- Medtronic Percept RC neurostimulatorTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05422469, who can take part
- Record updated
- 1 October 2026