The Antidepressant Effects of rTMS After Ischemic Stroke
关键词
抽象
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).
日期
最后验证: | 12/31/2017 |
首次提交: | 04/30/2017 |
提交的预估入学人数: | 05/15/2017 |
首次发布: | 05/17/2017 |
上次提交的更新: | 01/15/2018 |
最近更新发布: | 01/17/2018 |
实际学习开始日期: | 11/19/2017 |
预计主要完成日期: | 05/30/2020 |
预计完成日期: | 05/30/2020 |
状况或疾病
干预/治疗
Device: active rTMS treatment
Device: sham rTMS treatment
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: active rTMS treatment received active rTMS treatment 20 times for 20 days | Device: active rTMS treatment active rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz, intensity=110% motor threshold(MT), times per train=200 seconds, trains=10, duration= 40 seconds, total times=20;localization of right DLPFC: frequency=1 Hz, intensity=100%MT, times per train=30 seconds, trains=10, duration= 10 seconds, total times=20. |
Sham Comparator: sham rTMS treatment received sham rTMS treatment 20 times for 20 days | Device: sham rTMS treatment sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20. |
资格标准
有资格学习的年龄 | 25 Years 至 25 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. 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]); 2. Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke; 3. Clear signs of neurological deficits in the acute phase; 4. Clear consciousness; 5. Right-handedness. Exclusion Criteria: 1. Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes; 2. Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.; 3. Severe systemic disease or ongoing neoplasia; 4. Ongoing post-operative recovery; 5. Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders; 6. Current or prior antidepressant use for any reason; 7. Addiction to drugs, alcohol or other substances; 8. Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect; 9. Pregnant or breast-feeding women; 10. Participation in other clinical research projects; 11. Refusal to sign informed consent of this study. |
结果
主要结果指标
1. response rate [baseline, 2nd and 4th week]
2. remission rate [baseline, 2nd and 4th week]
次要成果指标
1. DTI results of FA [baseline and 4th week]
2. DTI results of ADC [baseline and 4th week]
3. DTI results of NFN [baseline and 4th week]
4. Neuropsychological tests results of NIHSS [baseline and 4th week]
5. Neuropsychological tests results of ADLs [baseline and 4th week]
6. Neuropsychological tests results of MoCA [baseline and 4th week]
7. Neuropsychological tests results of ABC [baseline and 4th week]
8. Neuropsychological tests results of SSRS [baseline and 4th week]
9. Neuropsychological tests results of MCMQ [baseline and 4th week]
10. Neuropsychological tests results of CGI [baseline and 4th week]