Clinical Trial

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

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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.
Protocol Amendment History 1 change
notable Sponsor changed: Tri-Service General Hospital -> Tri-Service General Hospital (TSGH) 2026-07-05
Trial Details
NCT Number NCT07327385
Lead Sponsor Tri-Service General Hospital
Conditions Posttraumatic Stress Disorder (PTSD), Depression - Major Depressive Disorder
Enrollment 50 participants
Start Date 2026-02-09
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-17