Repetitive Transcranial Magnetic Stimulation for Depression After Basal Ganglia Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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
- response rate
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of rTMS in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.The primary outcome is the measurement of 24-item Hamilton Depression Rating Scale (HAMD-24) scores, and the secondary outcomes include diffusion tensor imaging (DTI) results and the results of neuropsychological tests including National Institutes of Health Stroke Scale (NIHSS), Activities of Daily Living Scale (ADLs), Montreal Cognitive Assessment (MoCA),Clinical Global Impressions scales(CGI), Aphasia Battery in Chinese (ABC), Social Support Revalued Scale (SSRS) and Medical Coping Questionnaire (MCMQ).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia ischemic stroke and a diagnosis of depression due to stroke based on The Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and The International Classification of Diseases-10 (ICD-10-CM code 293.83[F06.32]);
- •Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke;
- •Clear signs of neurological deficits in the acute phase;
- •Clear consciousness;
- •Right-handedness.
排除标准
- •Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes;
- •Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.;
- •Severe systemic disease or ongoing neoplasia;
- •Ongoing post-operative recovery;
- •Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders;
- •Current or prior antidepressant use for any reason;
- •Addiction to drugs, alcohol or other substances;
- •Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect;
- •Pregnant or breast-feeding women;
- •Participation in other clinical research projects;
- •Refusal to sign informed consent of this study.
研究组 & 干预措施
active rTMS treatment
received active rTMS treatment 20 times for 20 days
干预措施: active rTMS treatment (Device)
sham rTMS treatment
received sham rTMS treatment 20 times for 20 days
干预措施: sham rTMS treatment (Device)
结局指标
主要结局
response rate
时间窗: baseline, 2nd and 4th week
Compare the HAMD-24 scores from baseline to the end of the treatment.the response to treatment is defined as at least a 50% reduction of the HAMD-24 total score with a final HAMD-24 score below 9. The response rate is defined as the percentage of number of response.
remission rate
时间窗: baseline, 2nd and 4th week
Compare the HAMD-24 scores from baseline to the end of the treatment. The remission is defined as a reduction of the HAMD-24 total score by at least 50% from the baseline. The remission rate is defined as the percentage of number of remission.
次要结局
- DTI results of FA(baseline and 4th week)
- DTI results of ADC(baseline and 4th week)
- DTI results of NFN(baseline and 4th week)
- Neuropsychological tests results of NIHSS(baseline and 4th week)
- Neuropsychological tests results of ADLs(baseline and 4th week)
- Neuropsychological tests results of MoCA(baseline and 4th week)
- Neuropsychological tests results of ABC(baseline and 4th week)
- Neuropsychological tests results of SSRS(baseline and 4th week)
- Neuropsychological tests results of MCMQ(baseline and 4th week)
- Neuropsychological tests results of CGI(baseline and 4th week)