Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

PTSD Clinical Trial

Official title:

Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120635
• Other study ID #: 21-000697
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: Sonja Hiller
• Phone: 3107947517
• Email: suthanalab[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

• Pregnant women

• Participants with active psychosis

• Participants with suicidal ideation

• Participants with substance abuse issues

Related Conditions & MeSH terms

• Fear
• GAD
• PTSD

Intervention

Device:
• Deep Brain Stimulation
Deep brain stimulation will be used

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Physiological change - heart rate variability	heart rate variability will be measured in milliseconds.	during the intervention/behavioral tasks with and without stimulation
Primary	Physiological change - skin conductance	Skin conductance will be measured in microSiemens.	during the intervention/behavioral tasks with and without stimulation
Primary	Neurophysiological activity	Neurophysiological activity will be measured in Hz	during the intervention/behavioral tasks with and without stimulation