Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT05120635

Collaborator

National Institutes of Health (NIH) (NIH), VA Greater Los Angeles Healthcare System (U.S. Fed), NeuroPace (Industry)

Enrollment

Location

56.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fear GAD Emotional Memory PTSD	Device: Deep Brain Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Not a native English Speaker
Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90024

Sponsors and Collaborators

University of California, Los Angeles
National Institutes of Health (NIH)
VA Greater Los Angeles Healthcare System
NeuroPace

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanthia Suthana, Principal Investigator, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT05120635

Other Study ID Numbers:

21-000697

First Posted:

Nov 15, 2021

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 18, 2022