Skip to content

Neuroimaging Memories of Fear and Safety in the Human Brain

Localizing and Modulating Competing Memories of Fear and Safety in the Human Brain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04975009
Enrollment
240
Registered
2021-07-23
Start date
2021-07-12
Completion date
2025-12-31
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear Anxiety, PTSD

Keywords

Pavlovian conditioning, Fear Conditioning, Neuroimaging

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.

Detailed description

This study uses functional magnetic resonance imaging (fMRI) to investigate how the brain forms associations between neutral stimuli and a mildly uncomfortable electrical stimulation to the wrist. Referred to as Pavlovian fear conditioning. The goal is to compare brain activity between individuals with posttraumatic stress disorder (PTSD) and healthy control subjects without PTSD. PTSD is characterized by excessive fear and anxiety, including in harmless situations. The data here will help us better understand dysregulation in neural circuitry involved in fear recovery, which has implications for improving treatment.

Interventions

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.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

(All study populations): 1. 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). 2. A positive pregnancy test in female volunteers. 3. Benzodiazepines, tested using urine tox screen. 4. For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations. 5. For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month. 6. History of moderate to severe cannabis use disorder. 7. Magnetic Resonance Imaging (MRI) exclusions: Claustrophobia; tattoos above the shoulders; permanent eyeliner or permanent; artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; being a sheet-metal worker or welder; lifetime history of aneurysm surgery; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other metal implants. Inclusion Criteria (PTSD populations): 1. Meet diagnostic criteria for PTSD, as assessed by standard diagnostic instruments. 2. Participants with PTSD are eligible if they meet diagnostic criteria for current PTSD. This is determined by the presence of a Criterion A event in addition to a severity score of 2 or greater on 1 symptom in clusters B and C and on 2 symptoms in clusters D and E, in addition to meeting criteria F and G. The specific form of trauma is not considered for inclusion/exclusion. 3. Volunteers in the patient group, but not healthy control group, may also meet criteria for a mood disorder (except for bipolar affective disorder, see exclusions below), as well as other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). Including these comorbidities is essential because of the high frequency of co-occurring mood and anxiety disorders with PTSD.

Exclusion criteria

(all participants): 1. 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). 2. A positive pregnancy test in female volunteers. 3. Benzodiazepines, tested using urine tox screen. 4. For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations. 5. For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month. 6. History of moderate to severe cannabis use disorder. 7. MRI exclusions: Claustrophobia; tattoos above the shoulders; permanent eyeliner or permanent; artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; being a sheet-metal worker or welder; lifetime history of aneurysm surgery; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other metal implants.

Design outcomes

Primary

MeasureTime frameDescription
Change in physiological arousal throughout the experimental phases, compared between healthy controls and PTSD participantsthrough study completion, an average of 1 month.Skin conductance responses measure sweating throughout the experiment. We compare the magnitude of this response during each phase of the experiment between groups.
Change in functional MRI data in fear-learning circuitry throughout the experimental phases, compared between healthy controls and PTSD participantsthrough study completion, an average of 1 month.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.

Secondary

MeasureTime frameDescription
Individual differences in brain-behavior responsesthrough study completion, an average of 1 month.Individual participants arousal, as well as trait variable of anxiety and symptom severity, will be used as a covariate in neuroimaging analyses to assess brain-behavior correlations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026