Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
Pain is a common symptom experienced by people following stroke and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This is a pilot randomized control trial to test the effects of rTMS in stroke-related pain rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in daily livings activities. Furthermore, we will explore the effects on pressure pain threshold, cortical excitability and EEG recording.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of first stroke verified by brain imaging < 6 months
- •pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain and a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception
排除标准
- •medical conditions likely to interfere with the ability to safely complete the study protocol
- •cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30
- •intracranial metal implants
- •history of seizures or epilepsy
- •severe cardiopulmonary, renal, and hepatic diseases
- •pregnancy
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: Change measures (weeks: 0,2,6)
Core outcome measure of pain intensity in pain treatments' clinical trials
次要结局
- Short Form McGill Pain Questionnaire (SF-MPQ)(Change measures (weeks: 0,2,6))
- Beck Depression Inventory II (BDI-II)(Change measures (weeks: 0,2,6))
- Neuropathic Pain Symptom Inventory (NPSI)(Change measures (weeks: 0,2,6))
- Pressure Pain Threshold (PPT)(Change measures (weeks: 0,2,6))
- Motor cortex excitability (single pulse TMS)(Change measures (weeks: 0,2,6))
- Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version (EmNSA-I)(Change measures (weeks: 0,2,6))
- Fugl-Meyer Assessment - Upper Extremity (FM-UE)(Change measures (weeks: 0,2,6))
- Barthel Index (BI)(Change measures (weeks: 0,2,6))
- Electroencephalography (EEG) recordings(Change measures (weeks: 0,2,6))
研究者
Sofia Straudi
MD
University Hospital of Ferrara