Efficacy of Navigated Repetitive Transcranial Magnetic Stimulation in Treatment of Central Post Stroke Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Change in average pain compared to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Difficult aphasia
- •Contraindication for TMS or MRI
- •Alcohol and/or drug abuse
研究组 & 干预措施
Transcranial Magnetic Stimulation I
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the motor cortex
干预措施: navigated rTMS of motor cortex (Device)
Transcranial Magnetic Stimulation II
Intervention: Repetitive navigated Transcranial Magnetic Stimulation of the secondary somatosensory cortex
干预措施: navigated rTMS of somatosensory cortex 2 (Device)
Sham Stimulation
Intervention: Repetitive sham Transcranial Magnetic Stimulation with SHAM block of the motor cortex
干预措施: SHAM rTMS with SHAM block (Device)
结局指标
主要结局
Change in average pain compared to baseline
时间窗: 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.
次要结局
- Quality of life (EQ-5D)(One week after each arm of the study and 6 months after the last one)
- Depression(One week after each arm of the study and 6 months after the last stimulation)
- Change in average pain compared to baseline(2,3,4,5 and 6 months after the last stimulation)
- Magnetoencephalography (MEG)(One week before and after each arms stimulations)
- Number of patients with adverse effects(From the start to the end of the study, on average 12 months per patient.)
- Hands´ motor function and dexterity(One week before and after each arm of the study)
- Cold water test(One week before and after each arm of the study)
- Genetics(No time frame, just a blood sample)
研究者
Juhani Ojala
MD
Helsinki University Central Hospital