A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Aged between 18 to 65 years old
• Right handedness
• Have a diagnosis of PTSD meeting DSM-5 criteria
• CAPS-5 score\>35
• Under stable medication for at least four weeks
• Capable of independently reading and understanding study materials and providing informed consent.
Locations
Other Locations
China
First Affiliated Hospital of Anhui Medical University
RECRUITING
Hangzhou
Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Affiliated Kangning Hospital of Ningbo University
RECRUITING
Ningbo
Shanghai Mental Health Center
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Contact Information
Primary
Huiqian Huang, Ph.D.
hhq0301@zju.edu.cn
+8618757143725
Backup
Shanshan Li, Bachelor
1252037349@qq.com
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 140
Treatments
Sham_comparator: Sham stimulation
A sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation.
Active_comparator: Active stimulation
An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days).
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Shanghai Mental Health Center, The Affiliated Kangning Hospital of Ningbo University, Tongji Hospital, The First Affiliated Hospital of Anhui Medical University