Non-invasive Brain Stimulation in SCI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
研究概览
简要总结
to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. This modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. Through the use of repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time to complete a peg-board task in four chronic incomplete cervical SCI patients.
Physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to optimize the functional outcome for a given individual. Hypothesized was that high-frequency rTMS coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete SCI patients to a greater degree than sham stimulation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had subacute motor incomplete SCI (AIS-C or D),
- •candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;
- •stable medical treatment at least one week before and during the study;
- •without limitation of passive range of movement in joints
- •agreed to participate after signing a written informed consent form.
排除标准
- •unstable clinical state
- •severe spasticity (MAS>=3)
- •disagreed to sign consent form
结局指标
主要结局
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
时间窗: Change from Baseline 10MWT at 4 and 8 weeks
Patients with or without orthesis were asked to walk at their fastest but most comfortable speed and step length and cadence assessed during the 10MWT (We added the number of steps taken in 10 m. Step length (meters)=distance (m) x 2 / number of stops (heel to heel of same foot). Cadence (steps/min.)=number of steps x 60 / time (seconds))
次要结局
- --Total motor score from upper (UEMS) and lower extremities (LEMS)(Change from Baseline 1UEMS and LEMS at 4 and 8 weeks)
- Modified Ashworth Scale (MAS)(Change from Baseline MAS at 4 weeks)
- Walking Index for SCI (WISCI) II(Change from Baseline WISCI-II at 4 and 8 weeks)
研究者
Joan Vidal
MD, PhD
Institut Guttmann