Fear AnxietyNCT04975009
Neuroimaging Memories of Fear and Safety in the Human Brain
A study testing Fear conditioning in people with Fear Anxiety and PTSD, run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Anxiety, PTSD
- What is being tested?
- Fear conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations.
- For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month.
- History of moderate to severe cannabis use disorder.
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- 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.
- Meet diagnostic criteria for PTSD, as assessed by standard diagnostic instruments.
- 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.
- 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.
Who cannot join
- 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.
- For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations.
- For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month.
- History of moderate to severe cannabis use disorder.
Show all 11Show fewer
- 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.
- 1. 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.
- 2. Volunteers meeting DSM-5 criteria for another substance use disorder, with the exception of caffeine or nicotine, within the past 12 months.
- 3. 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.
- 4. Participants must be stable on medication.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78705
Joseph Dunsmoor, PhD, 512-495-5144, joseph.dunsmoor@austin.utexas.edu
- Recruiting
Biomedical Imaging Center
Austin, Texas, 78712
Donald Nolting, 512-232-4203, support@biomedimaging.utexas.edu
About this study
Official title: Localizing and Modulating Competing Memories of Fear and Safety in the Human Brain
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.
Read the 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.
- Conditions
- Fear Anxiety, PTSD
- Being tested
- Fear conditioning
- Keywords
- Pavlovian conditioning, Fear Conditioning, Neuroimaging
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear conditioningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Fear conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 month.
Secondary outcomes (1)
Individual differences in brain-behavior responses
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.
Measured: through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start12 Jul 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph E. Dunsmoor, Jr., University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975009
- Sponsor's protocol ID
- 2020020157-MODCR01
- Status last verified
- May 2022
- First submitted
- 6 Jul 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localizing and Modulating Competing Memories of Fear and Safety in the Human Brain
- ClinicalTrials.gov ID
- NCT04975009
- Acronym / sponsor ID
- 2020020157-MODCR01
- Conditions
- Fear Anxiety, PTSD
- Keywords
- Pavlovian conditioning, Fear Conditioning, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD group | Experimental | Behavioral: Fear conditioningParticipants 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. |
| Healthy control group | Experimental | Behavioral: Fear conditioningParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
- For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations.
- For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month.
Key exclusion criteria (11 listed)
- 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.
- For the healthy subjects, exclusion is meeting criteria for either PTSD, or any other psychiatric disorder, or any prior psychiatric hospitalizations.
- For the healthy subjects, exclusion is prior use of a psychotropic medication for longer than 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear conditioningParticipants 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. | Behavioural | Healthy control group, PTSD group |
Primary outcome
Change in physiological arousal throughout the experimental phases, compared between healthy controls and PTSD participants
Time frame: through 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 participants
Time frame: through 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.
1 secondary outcome
Individual differences in brain-behavior responses
Time frame: through study completion, an average of 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear conditioning in people with Fear Anxiety and PTSD, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physiological arousal throughout the experimental phases, compared between healthy controls and PTSD participants (time frame: through study completion, an average of 1 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.