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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Fear; GAD; Emotional Memory
• Intervention / Treatment: Device: Deep Brain Stimulation; Behavioral: Virtual and augmented reality tasks

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Vilchez; Phone Number: 9196812577; Email: suthanalab@duke.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Recruiting
      • University of California Los Angeles
      • Contact: Sonja Hiller; Phone Number: 919-681-2577; Email: suthanalab@mednet.ucla.edu
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Health System
      • Contact: Gabriela Vilchez; Phone Number: 919-681-2577; Email: suthanalab@duke.edu
      • Principal Investigator: Nanthia Suthana, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EMU Participants; Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).	Device: Deep Brain Stimulation; Deep brain stimulation will be used; Behavioral: Virtual and augmented reality tasks; Virtual and augmented reality tasks will be used.
Other: RNS Participants; Subjects with RNS implants.	Device: Deep Brain Stimulation; Deep brain stimulation will be used; Behavioral: Virtual and augmented reality tasks; Virtual and augmented reality tasks will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological change - eye-blinks	Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.	during the intervention/behavioral tasks with and without stimulation
Physiological change - heart rate variability	heart rate variability will be measured in milliseconds.	during the intervention/behavioral tasks with and without stimulation
Physiological change - skin conductance	Skin conductance will be measured in microSiemens.	during the intervention/behavioral tasks with and without stimulation
Neurophysiological activity	Neurophysiological activity will be measured in Hz	during the intervention/behavioral tasks with and without stimulation

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH); NeuroPace; VA Greater Los Angeles Healthcare System
• Investigators: Principal Investigator: Nanthia Suthana, PhD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Therapeutics; Surgical Procedures, Operative; Electric Stimulation Therapy; Deep Brain Stimulation
• Other Study ID Numbers: PRO00118015; R01MH124761 (U.S. NIH Grant/Contract); Pro00117931 (Duke University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements
• IPD Sharing Time Frame: All data will be provided by the time publication occurs or when the proposed funding period has ended.
• IPD Sharing Access Criteria: Researchers can request access to the data under collaborative and coauthorship agreements prior to the end of the funding period or before publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No