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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTri-Service General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders.

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.

Trial design

Treatments tested in this trial

  • Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS)
  • High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)
  • Sham Transcranial Magnetic Stimulation

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators