LIFU Mechanisms for PTSD in Healthcare Workers
ConditionPTSD and Trauma-related Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaureate Institute for Brain Research, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Low intensity focused ultrasound
DeviceLow intensity focused ultrasound neuromodulation of the ventral anterior cingulate cortex
Sham modulation
DeviceLow intensity focused ultrasound with a Sorbothane membrane cover to prevent acoustic energy transmission
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Low intensity focused ultrasound (LIFU)Experimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
LIFU target engagement
Percent BOLD signal change in vACC and amygdala regions of interest
Time frame
Study day 1 to day 7 (plus or minus 3 days)2
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.
Time frame
Day 0 to Day 7 (plus or minus 3 days)Secondary outcomes
1
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
Time frame
Day 0 to day 14 (plus or minus 6 days)2
LIFU effects on PTSD symptoms
Change in PCL-5 score
Time frame
Dy 0 to day 14 (plus or minus 6)3
fMRI-heart rate variability correlation
Correlations between vACC/amygdala BOLD signal extracted beta-weights and heart rate variability (ms) as measured by Oura Ring
Time frame
Day 0 to day 14 (plus or minus 6)4
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
Time frame
Day 0 to day 14 (plus or minus 6)Sponsors and contacts
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Source ClinicalTrials.gov