Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
3 other identifiers
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 16, 2025
September 1, 2025
4.7 years
October 4, 2021
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
EMU Participants
OTHERSubjects participating in the study at the Epilepsy Monitoring Unity (EMU).
RNS Participants
OTHERSubjects with RNS implants.
Interventions
Virtual and augmented reality tasks will be used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- VA Greater Los Angeles Healthcare Systemcollaborator
- NeuroPacecollaborator
- Duke Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (2)
University of California Los Angeles
Los Angeles, California, 90024, United States
Duke University Health System
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nanthia Suthana, PhD
Duke Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 15, 2021
Study Start
October 1, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share