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NCT Number: NCT05120635

Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

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.

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Key information

Conditions

Fear Emotional Memory GAD Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

Deep brain stimulation will be used

Virtual and augmented reality tasks

Behavioral

Virtual and augmented reality tasks will be used.

Primary outcomes

  1. Physiological change - eye-blinks

    Time frame: during the intervention/behavioral tasks with and without stimulation

    Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.

  2. Physiological change - heart rate variability

    Time frame: during the intervention/behavioral tasks with and without stimulation

    heart rate variability will be measured in milliseconds.

  3. Physiological change - skin conductance

    Time frame: during the intervention/behavioral tasks with and without stimulation

    Skin conductance will be measured in microSiemens.

  4. Neurophysiological activity

    Time frame: during the intervention/behavioral tasks with and without stimulation

    Neurophysiological activity will be measured in Hz

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Vilchez

CONTACT

[email protected]

9196812577

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)
  • NeuroPace
  • VA Greater Los Angeles Healthcare System

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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