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Clinical Trials/NCT05120635
NCT05120635
Recruiting
Not Applicable

Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Duke University2 sites in 1 country80 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fear
Sponsor
Duke University
Enrollment
80
Locations
2
Primary Endpoint
Neurophysiological activity
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
June 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Neurophysiological activity

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

Neurophysiological activity will be measured in Hz

Physiological change - heart rate variability

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

heart rate variability will be measured in milliseconds.

Physiological change - skin conductance

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

Skin conductance will be measured in microSiemens.

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.

Study Sites (2)

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