To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Tr… (NCT07327385) | Clinical Trial Compass
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To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder
Taiwan50 participantsStarted 2026-02-09
Plain-language summary
This study aims to investigate the immediate neurophysiological and autonomic effects of two noninvasive brain stimulation protocols-prolonged intermittent theta-burst stimulation (prolonged iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)-in patients with posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Using a randomized, double-blind, sham-controlled crossover design, changes in prefrontal cortical activity measured by functional near-infrared spectroscopy (fNIRS) and autonomic nervous system function measured by heart rate variability (HRV) will be assessed before and immediately after a single stimulation session.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults aged 18 to 65 years.
✓. Clinical diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 criteria, confirmed by a board-certified psychiatrist.
✓. Presence of comorbid major depressive disorder with stable clinical condition.
✓. PTSD symptom severity defined as: PTSD Checklist for DSM-5, Chinese version (C-PCL-5) total score ≥ 31.
✓. Depressive symptom severity defined as: Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10.
✓. Stable psychiatric medication regimen for at least 4 weeks prior to enrollment, or medication-free.
✓. Ability to understand the study procedures and provide written informed consent.
✓. Normal or corrected-to-normal vision and hearing.
Exclusion criteria
✕. Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders.
What they're measuring
1
Change in Prefrontal Cortical Activation
Timeframe: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period
✕. Alcohol or substance use disorder (excluding caffeine and nicotine) within the past 6 months.
✕. Ongoing trauma-focused psychotherapy during the study period.
✕. Prior exposure to repetitive TMS treatment exceeding five sessions.
✕. Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation.
✕. Self-injurious behavior requiring medical attention within the past 3 months.
✕. History of epilepsy, seizure disorder, or family history of epilepsy.
✕. Significant neurological disorders, severe traumatic brain injury, or history of brain surgery.