Development and Application of a Novel Neurorehabilitation Technology With Paired Associative Nerve Stimulation in Spinal Cord Injured Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change of Motor evoked potentials (MEP)
研究概览
简要总结
This study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) combined with trans-spinal electrical stimulation (tsES) intervention on cortical excitability, brain structure, motor ability of lower limb in individuals with incomplete spinal cord injury. Twelve participants will be recruited in this study.
详细描述
Spinal cord injury (SCI) impairs motor and sensory function and affects numerous body functions and daily activities. Insufficient central nervous system plasticity can result in maladaptive changes that prevent full recovery. It's a challenge to guide this plasticity to optimize the functional outcome for individuals with SCI.
Transcranial magnetic stimulation (TMS) and trans-spinal electric stimulation (tsES) may modulate cortical excitability, corticospinal output and spinal circuit. However, few studies investigated the effectiveness of paired nerve stimulation (PNS) on neuroplasticity and functional outcome in persons with SCI. Therefore, this study aim to examine the effects of the combination of these two different non-invasive nerve stimulation with the cycling exercise on the motor cortex and corticospinal circuit excitability as well as functional recovery.
Present study clarifies the effects of five different settings of combined with TMS and tsES intervention and then undergo cycling exercise after PNS on spinal cord and cortical excitability in SCI participants.
It is expected that this project will successfully establish a new neuromodulation technology to enhance cortical, corticospinal and spinal circuit excitability as well as to improve the outcome of lower-limb function and quality of life in persons with SCI. Therefore, this project can not only publish scientific papers, but also can enhance the neuroplasticity and improve function in persons with SCI.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 65 years incomplete SCI (American Spinal Injury Association Impairment Scale (ASIA) B to D)
- •Lesion area above the tenth thoracic vertebra (T10)
- •Injury time more than one year
- •Without range of motion (ROM) limitation
- •Medical condition stable
排除标准
- •Having pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
- •Having seizure history
- •Having other neurological, mental, medical problems affect this study
结局指标
主要结局
Change of Motor evoked potentials (MEP)
时间窗: Just before the intervention start and immediately after the intervention finished.
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their one hand in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimized site, stimuli are delivered over various points around the Cz (approximate 1 cm distance from Cz). The optimal site is the location around the Cz that evoked the greatest MEP amplitude in tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Change of resting motor threshold (RMT)
时间窗: Just before the intervention start and immediately after the intervention finished.
Resting motor threshold (RMT) is recorded from tibialis anterior muscles following transcranial magnetic stimulation. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points around the Cz (the distance approximate 1 cm from Cz) to get the hot spot point. And then measure the RMT using the minimum stimulus intensity that produced a minimal motor evoked response (about 50 micro-volts (µV) in at least 5 of 10 trials) at rest.
次要结局
- Change of Surface Electromyography (sEMG)(Just before the intervention start and immediately after the intervention finished.)
- Change of functional Magnetic Resonance Imaging (fMRI)(Immediately after the intervention finished.)
- Change of Modified Ashworth Scale (MAS)(Just before the intervention start and immediately after the intervention finished.)
- Change of Lower Extremities Motor Score (LEMS)(Just before the intervention start and immediately after the intervention finished.)
研究者
Lai chien hung
Professor
Taipei Medical University Hospital