Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Duke University

Status: Enrolling

Conditions: Fear; PTSD; GAD; Emotional Memory

Treatments: Device: Deep Brain Stimulation; Behavioral: Virtual and augmented reality tasks

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency; NIH

Identifiers

NCT05120635

PRO00118015

R01MH124761 (U.S. NIH Grant/Contract)

Pro00117931 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 2 patient groups

EMU Participants

Other group

Description:

Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).

Treatment:

Behavioral: Virtual and augmented reality tasks

Device: Deep Brain Stimulation

RNS Participants

Other group

Description:

Subjects with RNS implants.

Treatment:

Behavioral: Virtual and augmented reality tasks

Device: Deep Brain Stimulation