Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
| The Affiliated Kangning Hospital of Ningbo University | UNKNOWN |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.
Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.
The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation | Sham Comparator | 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 stimulation | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham stimulation | Device | sham theta-burst transcranial magnetic stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks after finishing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Symptom Severity | Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). | Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment |
| Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqian Huang, Ph.D. | Contact | +8618757143725 | hhq0301@zju.edu.cn | |
| Shanshan Li, Bachelor | Contact | 1252037349@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Shen, M.D., Ph.D. | Shanghai Mental Health Center | Principal Investigator |
| Chang Yu, M.D. | The Affiliated Kangning Hospital of Ningbo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Tongji Hospital |
| OTHER |
Sham stimulation is used as a parallel control group for iTBS group.
Not provided
Not provided
Participants, investigators and outcomes assessors are all blind to the group assignments.
| intermittent theta-burst stimulation (iTBS) |
| Device |
intermittent theta-burst transcranial magnetic stimulation |
|
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. |
| Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment |
| 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. | Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment |
| 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. | Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment |
| change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | Q-LES-Q-SF is a patient-reported 16-item instrument that measures the degree of enjoyment and satisfaction in daily life over the past week. Individual items are rated on a scale from 1-5 ('very poor', 'poor', 'fair', 'good', or 'very good'). The Q-LES-Q-SF total score is the sum of the first 14 item scores (i.e. excluding medication satisfaction and overall life satisfaction and contentment) with a higher score indicating greater satisfaction (range = 14-70). | Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment |
| Change in neural activity pattern and functional connectivity of the brain based on fMRI | Structural, resting-state and task-based fMRI will be performed if the participant agree. During task-fMRI, the participant will listen to a script around one minute recorded during his/her first interview, describing the traumatic experience in details. The participant will be instructed to recall the traumatic experience vividly during the task-fMRI. Brain activity patterns and connectivity network will be presented and analyzed. | Baseline, 20 times treatment, 4 weeks after finishing treatment |
| Kai Wang, M.D., Ph.D. |
| The First Affiliated Hospital of Anhui Medical University |
| Principal Investigator |
| Xiaoming Li, M.D., Ph.D. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| First Affiliated Hospital of Anhui Medical University | Recruiting | Hangzhou | Zhejiang | China |
|
| Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| The Affiliated Kangning Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | China |
|