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NCT07327385

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

Sponsor: Tri-Service General Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-09

Completion Date

2028-12-31

Last Updated

2026-02-17

Healthy Volunteers

Conditions

Posttraumatic Stress Disorder (PTSD)Depression - Major Depressive Disorder

Interventions

DEVICE

Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS)

Prolonged intermittent theta-burst stimulation is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation is administered at 80% of individual motor threshold using an intermittent theta-burst pattern (2 seconds on, 8 seconds off), consisting of 3-pulse bursts at 50 Hz repeated at 5 Hz. A single session lasts approximately 9.5 minutes and delivers a total of 1,800 pulses.

DEVICE

High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)

High-frequency rTMS is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation follows the DASH protocol at 120% of motor threshold and 10 Hz frequency, with 4-second stimulation trains (40 pulses per train) followed by an 11-second inter-train interval, for a total of 75 trains. The single-session duration is approximately 18.75 minutes, delivering 3,000 pulses.

DEVICE

Sham Transcranial Magnetic Stimulation

Sham stimulation is delivered using a placebo coil identical in appearance and acoustic output to the active coil but without producing a magnetic field sufficient to induce cortical stimulation. Sham sessions match the corresponding active stimulation protocol in duration and procedure to maintain blinding.

Inclusion Criteria: 1. Adults aged 18 to 65 years. 2. Clinical diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 criteria, confirmed by a board-certified psychiatrist. 3. Presence of comorbid major depressive disorder with stable clinical condition. 4. PTSD symptom severity defined as: PTSD Checklist for DSM-5, Chinese version (C-PCL-5) total score ≥ 31. 5. Depressive symptom severity defined as: Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10. 6. Stable psychiatric medication regimen for at least 4 weeks prior to enrollment, or medication-free. 7. Ability to understand the study procedures and provide written informed consent. 8. Normal or corrected-to-normal vision and hearing. 9. Ability to comply with study procedures and visit schedule. Exclusion Criteria: 1. Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders. 2. Alcohol or substance use disorder (excluding caffeine and nicotine) within the past 6 months. 3. Ongoing trauma-focused psychotherapy during the study period. 4. Prior exposure to repetitive TMS treatment exceeding five sessions. 5. Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation. 6. Self-injurious behavior requiring medical attention within the past 3 months. 7. History of epilepsy, seizure disorder, or family history of epilepsy. 8. Significant neurological disorders, severe traumatic brain injury, or history of brain surgery. 9. Presence of implanted metallic or electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators). 10. Uncontrolled major medical illnesses or severe cardiovascular disease. 11. Pregnancy or breastfeeding. 12. Skin lesions or infections at the stimulation site. 13. Use of medications known to significantly lower seizure threshold (e.g., tricyclic antidepressants or certain analgesics). 14. Any condition deemed by the investigator to render the participant unsuitable for rTMS.

Locations (1)

Tri-Service General Hospital

Taipei, Neihu, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)