A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change in PTSD Symptom Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators and outcomes assessors are all blind to the group assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Previous experience of rTMS
- •Pregnancy/lactation, or planning to become pregnant during the study
- •Current under psychological or other physical treatments
研究组 & 干预措施
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.
干预措施: sham stimulation (Device)
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).
干预措施: intermittent theta-burst stimulation (iTBS) (Device)
结局指标
主要结局
Change in PTSD Symptom Severity
时间窗: Baseline and 4 weeks after finishing treatment
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.
次要结局
- change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(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(Baseline, 20 times treatment, 4 weeks after finishing treatment)
- Change in PTSD Symptom Severity(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(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(Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment)
- Change in The Personal Social Performance (PSP) scale(Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment)