Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05120635

Conditions

Fear

GAD

Emotional Memory

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Deep Brain Stimulation

Virtual and augmented reality tasks

Study Details

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.

Conditions

Fear

GAD

Emotional Memory

PTSD

Study ID

NCT05120635

Start date

Oct 1, 2021

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: EMU Participants

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

other: RNS Participants

Subjects with RNS implants.

Interventions

Deep Brain Stimulation

Deep brain stimulation will be used

Virtual and augmented reality tasks

Virtual and augmented reality tasks will be used.

Primary outcome measure

  • Physiological change - eye-blinks [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
  • Physiological change - heart rate variability [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
  • Physiological change - skin conductance [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
  • Neurophysiological activity [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]

Central Contacts and Locations

Central contacts

Aaron Halvorsen, PhD

9196812577suthanalab@duke.edu

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90024

Contacts

Sonja Hiller

9196812577suthanalab@mednet.ucla.edu

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Gabriela Vilchez

9196812577suthanalab@duke.edu

Principal Investigator:

Nanthia Suthana, PhD

More Information

Sponsor

Duke University

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-31.