PTSD and Trauma-related SymptomsNCT07164105
LIFU Mechanisms for PTSD in Healthcare Workers
A study testing Low intensity focused ultrasound in people with PTSD and Trauma-related Symptoms, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether low-intensity focused ultrasound (LIFU) of the ventral anterior cingulate cortex (vACC) can normalize dysfunctional brain activation patterns and behaviors in frontline healthcare workers with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD and Trauma-related Symptoms
- What is being tested?
- Low intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults in a frontline healthcare position (e.g. emergency medical services)
- Ages 18-65 years
- PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and < 65, OR at least partial PTSD as measured by the MINI
- English proficiency as evaluated by language ability during screening
Who cannot join
- Neurological disorders
- DSM-5 diagnosis of psychotic disorders, eating disorder, obsessive-compulsive disorder, moderate to severe alcohol or substance use disorder within the past year, bipolar disorder, or major depressive disorder with psychosis
- Suicidal intent or plan (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months.
- History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures
- Contraindications to MRI as determined by the MR Environment Screening
- Pregnancy, determined by urine pregnancy test administered prior to every MRI scanning procedure
Show all 11Show fewer
- Evidence of inability to comply with study procedures based on experimenter judgement.
- Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning, e.g., anxiolytics, antipsychotics, antidepressants, benzodiazepines, or mood stabilizers.
- Non-correctable vision or hearing problems
- Unstable medical diagnoses
- Any structural abnormalities in the LIFU target region on screening brain MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Adrienne Taren, MD, PhD, 918-340-4116, ataren@laureateinstitute.org
Courtney Kilpatrick, ckilpatrick@laureateinstitute.org
About this study
Official title: Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers
The goal of this clinical trial is to evaluate whether low-intensity focused ultrasound (LIFU) of the ventral anterior cingulate cortex (vACC) can normalize dysfunctional brain activation patterns and behaviors in frontline healthcare workers with post-traumatic stress disorder. The main questions it aims to answer are:
- Does LIFU of the vACC effect activity and connectivity of the vACC and amygdala?
- Does LIFU of the vACC reduce post-traumatic stress symptoms? Researchers will compare LIFU to sham modulation to see if LIFU modulates activity of vACC-amygdala circuitry and affects threat sensitivity and emotion regulation.
Read more
Participants will:
- Complete two fMRI sessions (before and after LIFU)
- Receive a single session of LIFU or sham modulation of the vACC
- Wear a wearable device that tracks sleep and heart rate metrics
Read the detailed description
The study employs a double-blind, randomized, sham-controlled design to evaluate whether low-intensity focused ultrasound (LIFU) targeting the ventral anterior cingulate cortex (vACC) can normalize fronto-limbic circuitry and reduce post-traumatic stress symptomatology in frontline healthcare workers. Sixty-six frontline healthcare professionals aged 18-65 (PCL-5 ≥ 33 or at least partial PTSD on the MINI) will complete baseline assessments that include structural MRI, resting-state fMRI, and two task-based scans. Concurrently, participants initiate continuous Oura Ring wearable monitoring and daily ecological momentary assessment (EMA) surveys. Subjects will return for active or sham LIFU neuromodulation of the vACC. Before and after LIFU, identical MRI and questionnaire batteries quantify acute neural and behavioral change.
- Conditions
- PTSD and Trauma-related Symptoms
- Being tested
- Low intensity focused ultrasound, Sham modulation
- 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.
Low intensity focused ultrasoundDevice
Also called LIFU
Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
Sham modulationDevice
Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission
| Study group | Role | What they receive |
|---|---|---|
| Low intensity focused ultrasound (LIFU) | Experimental | LIFU of the ventral anterior cingulate cortex Receives: Device: Low intensity focused ultrasound |
| Sham | Sham comparator | Sham neuromodulation (Sorbothane membrane over ultrasound probe) Receives: Device: Sham modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIFU target engagement
Percent BOLD signal change in vACC and amygdala regions of interest
Measured: Study day 1 to day 7 (plus or minus 3 days)
Behavioral changes
Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance.
Measured: Day 0 to Day 7 (plus or minus 3 days)
Secondary outcomes (8)
LIFU effects on physiology
Change in heart rate variability (ms), change in resting heart rate (beats per minute), change in %REM sleep (minutes), change in %deep sleep (minutes) as measured by Oura Ring
Measured: Day 0 to day 14 (plus or minus 6 days)
LIFU effects on PTSD symptoms
Change in PCL-5 score
Measured: Dy 0 to day 14 (plus or minus 6)
fMRI-heart rate variability correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and heart rate variability (ms) as measured by Oura Ring
Measured: Day 0 to day 14 (plus or minus 6)
fMRI-resting heart rate correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and resting heart rate (beats per minute) as measured by Oura ring
Measured: Day 0 to day 14 (plus or minus 6)
fMRI-REM sleep correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and %REM sleep (minutes) as measured by Oura ring
Measured: Day 0 to day 14 (plus or minus 6)
fMRI-deep sleep correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and %deep sleep (minutes) as measured by Oura ring
Measured: Day 0 to day 14 (plus or minus 6)
fMRI-PTSD Symptom Correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and PCL-5 score.
Measured: Day 0 to day 14 (plus or minus 6)
fMRI-Emotion Regulation Correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and Cognitive-Emotion Regulation Questionnaire Score.
Measured: Day 0 to day 14 (plus or minus 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start29 Dec 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD and Trauma-related SymptomsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164105
- Sponsor's protocol ID
- 20252812
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2025
- Last updated
- 20 Apr 2026
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Low Intensity Focused Ultrasound of the Ventral Anterior Cingulate Cortex for Post-Traumatic Stress Disorder in Frontline Healthcare Workers
- ClinicalTrials.gov ID
- NCT07164105
- Acronym / sponsor ID
- 20252812
- Conditions
- PTSD and Trauma-related Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Sep 2025 (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 goal of this clinical trial is to evaluate whether low-intensity focused ultrasound (LIFU) of the ventral anterior cingulate cortex (vACC) can normalize dysfunctional brain activation patterns and behaviors in frontline healthcare workers with post-traumatic stress disorder. The main questions it aims to answer are:
- Does LIFU of the vACC effect activity and connectivity of the vACC and amygdala?
- Does LIFU of the vACC reduce post-traumatic stress symptoms? Researchers will compare LIFU to sham modulation to see if LIFU modulates activity of vACC-amygdala circuitry and affects threat sensitivity and emotion regulation.
Participants will:
- Complete two fMRI sessions (before and after LIFU)
- Receive a single session of LIFU or sham modulation of the vACC
- Wear a wearable device that tracks sleep and heart rate metrics
Detailed description
The study employs a double-blind, randomized, sham-controlled design to evaluate whether low-intensity focused ultrasound (LIFU) targeting the ventral anterior cingulate cortex (vACC) can normalize fronto-limbic circuitry and reduce post-traumatic stress symptomatology in frontline healthcare workers. Sixty-six frontline healthcare professionals aged 18-65 (PCL-5 ≥ 33 or at least partial PTSD on the MINI) will complete baseline assessments that include structural MRI, resting-state fMRI, and two task-based scans. Concurrently, participants initiate continuous Oura Ring wearable monitoring and daily ecological momentary assessment (EMA) surveys. Subjects will return for active or sham LIFU neuromodulation of the vACC. Before and after LIFU, identical MRI and questionnaire batteries quantify acute neural and behavioral change.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity focused ultrasound (LIFU) | Experimental | Device: Low intensity focused ultrasoundLIFU of the ventral anterior cingulate cortex |
| Sham | Sham comparator | Device: Sham modulationSham neuromodulation (Sorbothane membrane over ultrasound probe) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults in a frontline healthcare position (e.g. emergency medical services)
- Ages 18-65 years
- PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and < 65, OR at least partial PTSD as measured by the MINI
- English proficiency as evaluated by language ability during screening
Key exclusion criteria (11 listed)
- Neurological disorders
- DSM-5 diagnosis of psychotic disorders, eating disorder, obsessive-compulsive disorder, moderate to severe alcohol or substance use disorder within the past year, bipolar disorder, or major depressive disorder with psychosis
- Suicidal intent or plan (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months.
- History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures
- Contraindications to MRI as determined by the MR Environment Screening
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 |
|---|---|---|
| Low intensity focused ultrasoundAlso: LIFULow intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex | Device | Low intensity focused ultrasound (LIFU) |
| Sham modulationLow intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission | Device | Sham |
Primary outcome
LIFU target engagement
Time frame: Study day 1 to day 7 (plus or minus 3 days)
Percent BOLD signal change in vACC and amygdala regions of interest
Behavioral changes
Time frame: Day 0 to Day 7 (plus or minus 3 days)
Change in reaction time (ms) and error rate (percentage of correct answers) on emotional conflict task; difference between optimal and observed flight initiation distance.
8 secondary outcomes
LIFU effects on physiology
Time frame: Day 0 to day 14 (plus or minus 6 days)
LIFU effects on PTSD symptoms
Time frame: Dy 0 to day 14 (plus or minus 6)
fMRI-heart rate variability correlation
Time frame: Day 0 to day 14 (plus or minus 6)
fMRI-resting heart rate correlation
Time frame: Day 0 to day 14 (plus or minus 6)
fMRI-REM sleep correlation
Time frame: Day 0 to day 14 (plus or minus 6)
fMRI-deep sleep correlation
Time frame: Day 0 to day 14 (plus or minus 6)
fMRI-PTSD Symptom Correlation
Time frame: Day 0 to day 14 (plus or minus 6)
fMRI-Emotion Regulation Correlation
Time frame: Day 0 to day 14 (plus or minus 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound in people with PTSD and Trauma-related Symptoms, run by Laureate Institute for Brain Research, Inc. at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrienne Taren, MD, PhD (918-340-4116, ataren@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIFU target engagement (time frame: Study day 1 to day 7 (plus or minus 3 days)). 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 20 Apr 2026.