Study on the Effect and Mechanism of Individualized and Precise Location Transcranial Magnetic Stimulation Based on Magnetic Resonance Imaging on Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 4 Weeks after the end of the 10 day treatment period
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of repetitive transcranial magnetic stimulation under precise localization for post-traumatic stress disorder
详细描述
Participants who meet the entry conditions and sign the informed consent will be divided into two groups. The stimulation target of each participant will be determined according to MRI. The test group will receive active transcranial magnetic stimulation for 10 consecutive days, and the control group will receive sham stimulation. Symptom severity is assessed by scales and audio and video recordings at baseline, during treatment period and follow-up.Blood samples will also be collected from patients prior to treatment and will be analyzed histologically to explore differences in response to the intervention and biological mechanisms in different subgroups of 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
- Double (Participant, Investigator)
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
- •The subject, regardless of gender, aged between 18 and 65 years, is admitted to the psychosomatic outpatient department of the First Affiliated Hospital of Air Force Medical University;
- •The subject meets the diagnostic criteria of post-traumatic stress disorder in Diagnostic and Statistical Manual of Mental Disorders-5;
- •The score of Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 > 33；
- •The subject can understand and is willing to strictly abide by the clinical trial protocol and signs the informed consent.
排除标准
- •The subject has serious physical diseases or diseases that may affect the central nervous system (such as tumor, syphilis, etc.);
- •Patients with PTSD who keep stable on their original medication/psychotherapy for more than 3 weeks before the start of the study or who have not taken the relevant therapeutic medication for more than 2 weeks before the start of the study will be included.Otherwise they will be excluded;
- •The subject had previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
- •The subject has contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies) and space phobia;
- •The subject has a history of contact with psychoactive substances or other mental diseases;
- •Those at high risk of suicide, or those who have committed suicide or serious self injury and need emergency intervention;
- •Pregnant, breastfeeding or planning pregnancy during the trial;
- •In the judgment of the investigator, the subject has other conditions that are not suitable for the study.
结局指标
主要结局
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 4 Weeks after the end of the 10 day treatment period
时间窗: Baseline and Week 4 after the end of the 10 day treatment period
Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 . Change = (Week 4 Score -Baseline Score).
次要结局
- Change in Hamilton Depression Scale（HAMD-17）scores from baseline to the end of 10 day treatment period(Baseline and 10 days)
- Change in Hamilton Anxiety Scale scores from baseline to 4 Weeks after the end of 10 day treatment period(Baseline and Week 4 after the end of 10 day treatment period)
- Changes of resting state functional connectivity from baseline to the end of the 10 day treatment period(Baseline and 10 days)
- Behavioral changes from baseline to the end of the 10 day treatment period(Baseline and 10 days)
- Change in Hamilton Anxiety Scale scores from baseline to the end of 10 day treatment period(Baseline and 10 days)
- Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores scores from baseline to the end of the 10 day treatment period(Baseline and 10 days)
- Change in Hamilton Depression Scale scores from baseline to 4 Weeks after the end of 10 day treatment period(Baseline and Week 4 after the end of 10 day treatment period)