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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Posttraumatic Stress Disorder (PTSD), Depression - Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT07327385

Run by

Tri-Service General Hospital (TSGH)

People needed

50

Starts

2026-02-09

Expected to finish

2028-12-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Ability to comply with study procedures and visit schedule.

You may not qualify if…

• 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.
• 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.
• Presence of implanted metallic or electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators).
• Uncontrolled major medical illnesses or severe cardiovascular disease.
• Pregnancy or breastfeeding.
• Skin lesions or infections at the stimulation site.
• Use of medications known to significantly lower seizure threshold (e.g., tricyclic antidepressants or certain analgesics).
• Any condition deemed by the investigator to render the participant unsuitable for rTMS.

Where it is running

• Tri-Service General Hospital — Taipei, Neihu, Taiwan

Full record on ClinicalTrials.gov

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