About this trial
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 criteria
Qualifiers
Aged between 18 to 65 years old
Right handedness
Have a diagnosis of PTSD meeting DSM-5 criteria
CAPS-5 score>35
Disqualifiers
Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
Trial design
Treatments tested in this trial
- sham stimulation
- intermittent theta-burst stimulation (iTBS)
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Shanghai Mental Health Center
Collaborator
The Affiliated Kangning Hospital of Ningbo University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Tongji Hospital
Collaborator