Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation in Individuals With SCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Latency, amplitude, and duration of the M-wave
研究概览
简要总结
This clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials.
The study aims to:
Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.
Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI.
The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health subjects:
排除标准
- •Musculoskeletal injuries on legs.
- •Osteoporosis.
- •SCI subjects:
- •Inclusion Criteria
- •Participants with chronic spinal cord injury, with injury duration greater than one year.
- •Exclusion Criteria
- •Current musculoskeletal or joint injuries in the lower limbs.
- •History of central or peripheral neuromuscular diseases.
- •Presence of a pacemaker.
- •Current use of antispastic or antidepressant medications.
- •Current venous thromboembolism or osteoporosis.
- •Impairment of the soleus H-reflex arc.
研究组 & 干预措施
Stage 1: Healthy people
Identify optimal tSCS parameters for non-invasive spinal stimulation.
干预措施: Transcutaneous spinal cord stimulation (tSCS) (Procedure)
Stage 2: SCI Patients
Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.
干预措施: Short-term Machine-Assisted Ankle Movement Training with tSCS (Procedure)
Stage 3:SCI Patients
Long-term clinical effects of combined tSCS and ankle movement training
干预措施: Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS (Procedure)
Stage 3:SCI Patients(Control)
Control Group
结局指标
主要结局
Latency, amplitude, and duration of the M-wave
时间窗: Baseline, 4 weeks
The M-wave will be elicited by direct electrical stimulation of the motor nerve (e.g., tibial nerve) and recorded using electromyography (EMG) from the target muscle (e.g., soleus muscle).
Latency and amplitude of the H-reflex
时间窗: Baseline, 4 weeks
The H-reflex will be elicited through electrical stimulation of the tibial nerve (or sciatic nerve) using electromyography (EMG) to record the resulting muscle response.
Level of Post-Activation Depression (PAD) of the H-reflex
时间窗: Baseline, 4 weeks
The H-reflex will be elicited by electrical stimulation of the tibial nerve (or other motor nerves), and PAD will be assessed by measuring the reduction in H-reflex amplitude following a series of repetitive stimuli. The amplitude of the H-reflex after repeated stimulation will be compared to the baseline single stimulus.
Latency and amplitude of the Posterior Root Muscle (PRM) reflex
时间窗: Baseline, 4 weeks
The PRM reflex will be elicited by stimulating the posterior roots of the spinal cord (typically via electrical stimulation of the dorsal roots), and the resulting muscle activity will be recorded using electromyography (EMG)
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).
时间窗: Baseline, 4 weeks
Muscle spasticity will be evaluated using the MAS, which grades the resistance encountered during passive movement of the affected limb (e.g., arm or leg). The scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Muscle Tone (Frequency, Hz)
时间窗: Baseline, 4 weeks
This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness.
Elasticity (Dynamic Stiffness, N/m)
时间窗: Baseline, 4 weeks
Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse
Stiffness (Decay, ms)
时间窗: Baseline, 4 weeks
This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness
Mechanical Stress (Creep, s) and Relaxation (S)
时间窗: Baseline, 4 weeks
These parameters measure the time it takes for muscle tissue to adapt to a sustained force (creep) and the time it takes for the muscle to return to a relaxed state after removing the force (relaxation).
次要结局
- Ankle Joint Range of Motion (ROM)(Baseline, 4 weeks)
- Knee Joint ROM(Baseline, 4 weeks)
- Foot pressure distribution and peak pressure.(Measured continuously during CPM)
- The score of 10-meter walking test (10MWT)(Baseline, 4 weeks.)
- Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score(Baseline, 4 weeks)
研究者
Ya-Ju Chang
Professor
Chang Gung University