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Набира участници Не е приложимо NCT07164105

LIFU Mechanisms for PTSD in Healthcare Workers

Не е приложима фаза (напр. обсервационно)
Заболявания: PTSD and Trauma-related Symptoms

Спонсор: Laureate Institute for Brain Research, Inc.

Налично на: БГ
Обобщение
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
Описание
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.
Кой може да участва
Inclusion Criteria: 1. Adults in a frontline healthcare position (e.g. emergency medical services) 2. Ages 18-65 years 3. PTSD Checklist for DSM-5 (PCL-5) score ≥ 33 and \< 65, OR at least partial PTSD as measured by the MINI 4. English proficiency as evaluated by language ability during screening Exclusion Criteria: 1. Neurological disorders 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.
Интервенции
Low intensity focused ultrasound
DEVICE
Sham modulation
DEVICE
Места на провеждане 1
САЩ (1)
Laureate Institute for Brain Research
Tulsa , Oklahoma
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
29.12.2025
Крайна дата
01.08.2028
Регистрационен номер
NCT07164105
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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