NCT07327385Not yet recruiting
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
The Pathophysiological Mechanisms and Novel Treatments Linking Stress and Mental Health Conditions -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: a Randomized, Double-blind, Crossover Study
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- 9 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Diseases
- Depression
- NCT number
- NCT07327385
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 9 Feb 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to repetitive TMS treatment exceeding five sessions.
- Presence of implanted metallic or electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators).
Other illness
- 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.
- Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation.
- History of epilepsy, seizure disorder, or family history of epilepsy.
- Significant neurological disorders, severe traumatic brain injury, or history of brain surgery.
- Uncontrolled major medical illnesses or severe cardiovascular disease.
- 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.
Other
- Ongoing trauma-focused psychotherapy during the study period.
- Self-injurious behavior requiring medical attention within the past 3 months.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.