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.
Aged between 18 to 65 years old
Right handedness
Have a diagnosis of PTSD meeting DSM-5 criteria
CAPS-5 score>35
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
Parallel
sham stimulation
Devicesham theta-burst transcranial magnetic stimulation
intermittent theta-burst stimulation (iTBS)
Deviceintermittent theta-burst transcranial magnetic stimulation
Change in PTSD Symptom Severity
Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.
Change in PTSD Symptom Severity
Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms.
Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
The IDS-SR is a 30-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. The 16-item Quick Inventory of Depressive Symptomatology (QIDS) is a new measure of depressive symptom severity derived from the 30-item IDS-SR and has highly acceptable psychometric properties.
Change in The Personal Social Performance (PSP) scale
The Personal and Social Performance Scale (PSP) is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders. The four main areas include (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors.
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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
