Neuroimaging Memories of Fear and Safety in the Human Brain

NCT04975009 | Unknown

• 1 other identifier: 2020020157-MODCR01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to use functional magnetic resonance imaging (fMRI) to investigate how the brain forms associations between neutral and negative stimuli. The ultimate goal is to understand the neural systems involved in regulating negative emotional responses to fearful stimuli.

Conditions

Fear Anxiety; PTSD

Keywords

Pavlovian conditioning; Fear Conditioning; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• Change in physiological arousal throughout the experimental phases, compared between healthy controls and PTSD participants

  Skin conductance responses measure sweating throughout the experiment. We compare the magnitude of this response during each phase of the experiment between groups.

  through study completion, an average of 1 month.

• Change in functional MRI data in fear-learning circuitry throughout the experimental phases, compared between healthy controls and PTSD participants

  Participants undergo scanning on a 3-Tesla MRI during all experimental phases. Blood-oxygen-level-dependent (BOLD) signal in key brain regions will be compared between groups.

  through study completion, an average of 1 month.

Secondary Outcomes (1)

• Individual differences in brain-behavior responses

  through study completion, an average of 1 month.

Study Arms (2)

PTSD group

EXPERIMENTAL

Participants will be screened and diagnosed using typical screening procedures and diagnostic criteria (e.g., the clinically administered PTSD scale). Participants also screened for contraindications for MRI. The learning paradigm inside the MRI scanner occurs over 3 days. The first two days are consecutive (back-to-back) and the third MRI visit is 1 month later. Participants are asked to look at a screen and listen to simple tones over headphones, while the experimenter measures brain activity and physiological measures of arousal (e.g., sweating from sensors on the hand). These visits will be scheduled within two weeks from the baseline and assessment visit.

Behavioral: Fear conditioning

Healthy control group

EXPERIMENTAL

Participants will be healthy adults without a history of psychiatric illness. Participants also screened for contraindications for MRI. The learning paradigm inside the MRI scanner occurs over 3 days. The first two days are consecutive (back-to-back) and the third MRI visit is 1 month later. Participants are asked to look at a screen and listen to simple tones over headphones, while the experimenter measures brain activity and physiological measures of arousal (e.g., sweating from sensors on the hand). These visits will be scheduled within two weeks from the baseline and assessment visit.

Behavioral: Fear conditioning

Interventions

Fear conditioning BEHAVIORAL

Participants will learn to associate neutral stimuli with a mildly uncomfortable electrical stimulation to the wrist. The intensity of the electrical stimulus is calibrated prior to the start of the experiment to a level deemed highly annoying but not painful by the participant.

Healthy control group; PTSD group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers with a major medical illness or a neurological disorder (e.g., Parkinson's Disease), or neurological abnormality including significant head trauma (loss of consciousness \> 5 min).
• A positive pregnancy test in female volunteers.
• Benzodiazepines, tested using urine tox screen.
• History of moderate to severe cannabis use disorder.
• Meet diagnostic criteria for PTSD, as assessed by standard diagnostic instruments.

You may not qualify if:

• Volunteers with a major medical illness or a neurological disorder (e.g., Parkinson's Disease), or neurological abnormality including significant head trauma (loss of consciousness \> 5 min).
• A positive pregnancy test in female volunteers.
• Benzodiazepines, tested using urine tox screen.
• History of moderate to severe cannabis use disorder.
• \. Volunteers meeting DSM-5 criteria for history of or current psychotic or bipolar affective disorders, a current eating disorder (bulimia, anorexia nervosa), or dissociative identity disorder.
• \. Volunteers meeting DSM-5 criteria for another substance use disorder, with the exception of caffeine or nicotine, within the past 12 months.
• \. Individuals considered an immediate suicide risk based on the Columbia Suicide Severity Scale (C-SSRS) or who would likely require hospitalization during the course of the study.
• \. Participants must be stable on medication.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (2)

The University of Texas at Austin

Austin, Texas, 78705, United States

RECRUITING

Biomedical Imaging Center

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 23, 2021
• Study Start: July 12, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

US (2)