Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDuke University

About this trial

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

Qualifiers

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

Disqualifiers

Unwilling to provide informed consent

Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement

Pregnant women

Participants with active psychosis

Trial design

Treatments tested in this trial

  • Deep Brain Stimulation
  • Virtual and augmented reality tasks

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

VA Greater Los Angeles Healthcare System

Collaborator

NeuroPace

Collaborator

National Institute of Mental Health (NIMH)

Collaborator