The Effects of Systematic, Repetitive Transcranial Magnetic Stimulation in Rehabilitation After Incomplete Spinal Cord Injury: Neuromuscular Adaptations and Recovery of Lower Limb Muscle Strength
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- 6 minutes walking test
研究概览
简要总结
The project will investigate whether repetitive transcranial magnetic stimulation (rTMS) can be used to potentiate/prime spinal cord injured patients' nervous systems for more intense rehabilitation exercise of longer duration - thus leading to greater recovery of motion function. The technique, in which a magnetic coil is positioned above the scalp and forms a magnetic field that activates the desired center of the brain (eg motor cortex), is used in clinical practice for the treatment of a number of disorders. However, although a combination of rTMS and gait training in SCI patients previously has proven beneficial, it is unknown whether additional functional gains can be achieved by combining rTMS and supervised, high-intensity resistance training.
In this project, 30 newly-admitted patients will be recruited and randomized to receive either active rTMS and strength training (n = 15) or sham (imitated) rTMS + strength training, in parallel with standard care. The investigators hypothesize that the active rTMS group will have superior gains in locomotor function and muscle mass, compared to the sham group.
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
- Triple (Participant, Care Provider, 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
- •sub-acute (<6 months) incomplete spinal cord injury
- •admitted at the SCIWDK for primary rehabilitation
排除标准
- •Medical history of multiple central nervous system lesions,
- •severe structural,
- •inflammatory or degenerative cerebral disorders,
- •epilepsy,
- •other neurological diseases,
- •lower limb peripheral injury,
- •or orthopedic injuries that may limit maximal effort contractions
结局指标
主要结局
6 minutes walking test
时间窗: Measures the change from baseline and after 8 weeks of intervention
Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.
Timed up and go test
时间窗: Measures the change from baseline and after 8 weeks of intervention
Measures the time (in seconds) it takes a person to get up from an ordinary chair with back and armrest, walk 3 meters, turn back to the chair and sit back.
Rate of force development
时间窗: Measures the change from baseline and after 8 weeks of intervention
Measures the explosive muscle force of the knee flexors and knee extensors.
Lower limb maximal muscle strength
时间窗: Measures the change from baseline and after 8 weeks of intervention
Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.
10 meter walking test
时间窗: Measures the change from baseline and after 8 weeks of intervention
Measures the time (in seconds) it takes to cover 10 meters during level-ground walking.
次要结局
- Modified Ashworth Scale(Measures the change from baseline and after 8 weeks of intervention)
- H-reflex test(Measures the change from baseline and after 8 weeks of intervention)
- Walking Index for Spinal Cord Injury test(Measures the change from baseline and after 8 weeks of intervention)
- Self-reported pain(Measures the change from baseline and after 8 weeks of intervention)
- Pressure algometry(Measures the change from baseline and after 8 weeks of intervention)
- Quantitative Sensory Testing(Measures the change from baseline and after 8 weeks of intervention)
- The International Standards for Neurological Classification of Spinal Cord Injury(Measures the change from baseline and after 8 weeks of intervention)
研究者
Helge Kasch
Medical Research Director, Associate Professor, Clinical Neurology, MD, PhD
Spinal Cord Injury Centre of Western Denmark