Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Part of paid clinical trials in Los Angeles, California.

Sponsor
Duke University
Study ID
NCT05120635
Status
Recruiting

Conditions

  • Emotional Memory
  • Fear
  • GAD
  • PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Deep Brain Stimulation — DEVICE
    Deep brain stimulation will be used
  • Virtual and augmented reality tasks — BEHAVIORAL
    Virtual and augmented reality tasks will be used.

Study Details

Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.

Key Dates

Start date
Oct 1, 2021
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: EMU Participants
    Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).
  • Other: RNS Participants
    Subjects with RNS implants.

Primary Outcome Measure

Physiological change - eye-blinks [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90024
Sonja Hiller
919-681-2577
Duke University Health SystemDurhamNorth Carolina27705
Gabriela Vilchez
919-681-2577
Nanthia Suthana, PhD (PRINCIPAL_INVESTIGATOR)

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