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Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
NCT05120635 · Duke University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 18 years of age or older
* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Willing to provide informed consent and participate in the study
* Ability to read and write English fluently
Exclusion Criteria:
* Unwilling to provide informed consent
* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
* Pregnant women
* Participants with active psychosis
* Participants with suicidal ideation
* Participants with substance abuse issues
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2021-10-01
Estimated completion: 2026-06-30
Last updated: 2025-12-16
Interventions
Device: Deep Brain StimulationBehavioral: Virtual and augmented reality tasks
Primary outcomes
- • Physiological change - eye-blinks (during the intervention/behavioral tasks with and without stimulation)
- • Physiological change - heart rate variability (during the intervention/behavioral tasks with and without stimulation)
- • Physiological change - skin conductance (during the intervention/behavioral tasks with and without stimulation)
Sponsor
Duke University · other
With: National Institutes of Health (NIH), VA Greater Los Angeles Healthcare System, NeuroPace, National Institute of Mental Health (NIMH)
Contacts & investigators
ContactGabriela Vilchez · contact · suthanalab@duke.edu · 9196812577
InvestigatorNanthia Suthana, PhD · principal_investigator, Duke Health
All locations (2)
University of California Los AngelesRecruiting
Los Angeles, California, United States
Duke University Health SystemRecruiting
Durham, North Carolina, United States