Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-12-29
2028-08-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Low intensity focused ultrasound (LIFU)
LIFU of the ventral anterior cingulate cortex
Low intensity focused ultrasound
Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
Sham
Sham neuromodulation (Sorbothane membrane over ultrasound probe)
Sham modulation
Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission
Interventions
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Low intensity focused ultrasound
Low intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
Sham modulation
Low intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ages 18-65 years
3. PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and \< 65
4. English proficiency as evaluated by language ability during screening
Exclusion Criteria
2. 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
3. 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.
4. History of severe traumatic brain injury (as indicated by score ≥ 3 on the Tulsa Head Injury Screen) or of skull fractures
5. Contraindications to MRI as determined by the MR Environment Screening
6. Pregnancy, determined by urine pregnancy test administered prior to every MRI scanning procedure
7. Evidence of inability to comply with study procedures based on experimenter judgement.
8. 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.
9. Non-correctable vision or hearing problems
10. Unstable medical diagnoses
11. Any structural abnormalities in the LIFU target region on screening brain MRI.
18 Years
65 Years
ALL
No
Sponsors
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Laureate Institute for Brain Research, Inc.
OTHER
Responsible Party
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Locations
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Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20252812
Identifier Type: -
Identifier Source: org_study_id
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