Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05120635
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
VA Greater Los Angeles Healthcare System
NeuroPace
Information provided by (Responsible Party):
Nanthia Suthana, University of California, Los Angeles

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


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


Primary Outcome Measures :
  1. Physiological change - eye-blinks [ Time Frame: 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.

  2. Physiological change - heart rate variability [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
    heart rate variability will be measured in milliseconds.

  3. Physiological change - skin conductance [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
    Skin conductance will be measured in microSiemens.

  4. Neurophysiological activity [ Time Frame: during the intervention/behavioral tasks with and without stimulation ]
    Neurophysiological activity will be measured in Hz



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120635


Contacts
Layout table for location contacts
Contact: Sonja Hiller 3107947517 suthanalab@mednet.ucla.edu

Locations
Layout table for location information
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Sonja Hiller    310-794-7517    suthanalab@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
VA Greater Los Angeles Healthcare System
NeuroPace
Layout table for additonal information
Responsible Party: Nanthia Suthana, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05120635    
Other Study ID Numbers: 21-000697
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Time Frame: All data will be provided by the time publication occurs or when the proposed funding period has ended.
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No