Efficacy of Transcranial Magnetic Stimulation (TMS) in Central Post Stroke Pain ( CPSP)
2018年10月22日 更新者：Juhani Ojala、Helsinki University Central Hospital
Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
The aim of the study is to evaluate the analgesic effects of navigated repetitive transcranial magnetic stimulation in central post stroke pain.
MRI based navigation is used to determine the exact locations for stimulation.
研究概览
地位
完全的
条件
详细说明
Central post stroke pain is often very resistant to treatment. TMS has been shown to be a promising tool in treating difficult pain conditions. The best sites for stimulation are still not known and navigation has been used only in few studies.
The aim is to evaluate the analgesic effects of Navigated Repetitive Transcranial Magnetic Stimulation ( nrTMS ) on pain in a three armed crossover study. The navigation is done by using magnetic resonance imaging and stereotactic camera system. The three arms include stimulation to M1, S2 and sham stimulation to M1. 10 Hz repetitive stimulation is given to a specified location once a day 5 days a week for two weeks in each of the three arms. A months washout period is kept between each arm of the study.
Pain and other variables are followed before, during and after the study for 6 months.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- MRI defined brain infarction or hemorrhage before or at the age of 65 years
- CPSP diagnostic criteria is met (definite), verified by a neurologist
- Stable analgesic medication
- Average pain NRS 4 or more
Exclusion Criteria:
- Epilepsy
- Difficult aphasia
- Dementia
- Contraindication for TMS or MRI
- Alcohol and/or drug abuse
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
|
Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
其他名称：
|
|
实验性的：Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
|
Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
其他名称：
|
|
假比较器：Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
|
Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in average pain compared to baseline
大体时间：1 month after each arm of the study
|
Patients will keep a pain diary for one week before stimulation and for two weeks after the stimulation.
A nurse will call the patient one month after the last stimulation.
|
1 month after each arm of the study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life (EQ-5D)
大体时间：One week after each arm of the study and 6 months after the last one
|
Questionnaire EQ-5D
|
One week after each arm of the study and 6 months after the last one
|
|
Depression
大体时间：One week after each arm of the study and 6 months after the last stimulation
|
Questionnaire
|
One week after each arm of the study and 6 months after the last stimulation
|
|
Change in average pain compared to baseline
大体时间：2,3,4,5 and 6 months after the last stimulation
|
Phone call ( Numeric Rating Scale (NRS) in rest and movement )
|
2,3,4,5 and 6 months after the last stimulation
|
|
Magnetoencephalography (MEG)
大体时间：One week before and after each arms stimulations
|
Changes in the irritability of the motor cortex and somatosensory cortex
|
One week before and after each arms stimulations
|
|
Number of patients with adverse effects
大体时间：From the start to the end of the study, on average 12 months per patient.
|
Adverse effects are followed actively
|
From the start to the end of the study, on average 12 months per patient.
|
|
Hands´ motor function and dexterity
大体时间：One week before and after each arm of the study
|
Nine hole peg, Pinch and Jamar
|
One week before and after each arm of the study
|
|
Cold water test
大体时间：One week before and after each arm of the study
|
Conditioned pain modulation (CPM)
|
One week before and after each arm of the study
|
|
Genetics
大体时间：No time frame, just a blood sample
|
Evaluation of genetical properties in terms of TMS related pain reduction
|
No time frame, just a blood sample
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eija Kalso, PhD, Prof.、Professor of Pain Research and Management, University of Helsinki. Director of the Multidisciplinary Pain Clinic, Department of Anaesthesia and Intensive Care Medicine Helsinki University Central Hospital
- 学习椅：Jyrki Mäkelä, MD, PhD、Head of laboratory, BioMag, Helsinki University Central Hospital
- 学习椅：Erika Kirveskari, MD, PhD、Head and Chief Physician of Clinical Neurophysiology at Medical Imaging Center, Helsinki University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年5月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2014年10月22日
首先提交符合 QC 标准的
2014年10月27日
首次发布 (估计)
2014年10月29日
研究记录更新
最后更新发布 (实际的)
2018年10月24日
上次提交的符合 QC 标准的更新
2018年10月22日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.