Central and Peripheral Neuroplasticity in Cervical Spinal Cord Injury Following Intensive Upper Limb Motor Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 7
- 主要终点
- changes in single pulse TMS: resting motor threshold
研究概览
简要总结
After spinal cord injury (SCI), there is a disruption in neural circuits resulting in paralysis. There is not yet a cure for paralysis. In persons with Cervical SCI (pwC-SCI) recovery of arm-hand function is very important as it has a significant impact on the patients' level of independence and quality of life. Recovery is assumed to involve alterations in both central and peripheral motor systems. Motor training at an intensive dosage potentially provides a powerful stimulus for neurological recovery. This project exploits the peripheral and central neuroplastic effect of an early (<13 weeks after injury) and intensive (8 weeks of 6 hours in addition to usual care) upper limb motor training program (EIUMT) directed at recovery below the level of the injury in pwC-SCI within an international multi-center randomized controlled trial including 44 pwC-SCI. It has 4 objectives: to investigate 1)central neural plasticity by identifying alterations in cortical neuroplasticity and corticospinal excitability; 2)peripheral neural plasticity by identifying alterations in axonal excitability and number of motor units; 3)behavioral motor recovery of upper limb and 4)relationships between dose dimensions of motor intervention and behavioral and neurophysiological outcome measures after EIUMT. Cutting-edge neurophysiological measures are used to provide insight in the mechanism of neuroplasticity after EIUMT and will be taken before and after EIUMT and at 6 months follow-up.
详细描述
Background of the study:
Paralysis or paralysis is the most common effect of spinal cord injury (SCI) on individuals. Paralysis affects the ability to walk, perform self-care, live independently and participate in work and leisure activities. In individuals with cervical spinal cord injury, arm and hand function is very important. The most promising and easily implemented intervention that could promote neurological recovery and make a lasting difference in the lives of people with spinal cord injuries is early and intensive motor training aimed at recovery below the injury level. This intervention takes advantage of the early plasticity of the nervous system. By maximizing muscle activation in the first few weeks after injury, we can target the nervous system's unique capacity for neural plasticity where changes can occur in central and peripheral motor systems.
Objective of the study:
This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT) aimed at recovery below the lesion level. This project has 4 objectives: to investigate 1) central neural plasticity (identify changes in cortical neuroplasticity and corticospinal excitability; 2) peripheral neural plasticity (identify change in axonal excitability and number of motor units); 3) clinical motor recovery of the upper limbs and 4) relationships between dose dimensions of motor intervention and clinical and neurophysiological outcome measures after EIUMT. Advanced neurophysiological measurements and clinical measurements will be taken before and after EIUMT and at 6-month follow-up.
Study design:
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 (Investigator)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic or non-traumatic C-SCI in the preceding 13 weeks; age over 16 years; have an incomplete SCI categorized as AIS C or D or an AIS A SCI with zones of partial motor paralysis (as defined by the International Standards for the Neurological Classification of SCI (ISNCI) and medically stable.
排除标准
- •SCI with ASIA Impairment Scale (AIS) A without zones of partial preservation (decided based on former studies) and expertise of the team; SCI with any significant medical condition that could prevent the person from participating. Patients will be excluded from the measures of central plasticity in the presence of contraindications for TMS application such as epilepsy, metal implants in the brain, defibrillator, pacemaker, and pregnancy
结局指标
主要结局
changes in single pulse TMS: resting motor threshold
时间窗: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
to asses changes in cortical reactivity
changes in GRASSP
时间窗: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Grades redefined assessment of strength sensibility and Prehension
Changes in Compound Muscle Action Potential (CMAP)
时间窗: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
Changes in amplitude of CMAP
changes in single pulse TMS: resting motor threshold
时间窗: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
to asses changes in cortical reactivity
Changes in Compound Muscle Action Potential (CMAP)
时间窗: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
Changes in amplitude of CMAP
changes in GRASSP
时间窗: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Grades redefined assessment of strength sensibility and Prehension
次要结局
- changes SICI(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- Single-pulse TMS: Stimulus Response Curve(- before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up)
- changes in LICI(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in NET (Nerve excitability testing)(- before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up)
- changes in behavioral measures: Upper extremity motor score(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in Spinal Cord independence Measures(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in Van Lieshout Test(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in hand held dynamometry(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- Single-pulse TMS: Stimulus Response Curve(- before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up)
- changes SICI(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in LICI(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in Spinal Cord independence Measures(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in Van Lieshout Test(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in hand held dynamometry(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- Goal satisfaction(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in MscanFit MUNE(- before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up)
- changes in single pulse TMS: mapping(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in behavioral measures: Upper extremity motor score(- before intervention; at 8 weeks (after intervention) and at 6 months follow-up)
- changes in NET (Nerve excitability testing)(- before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up)
研究者
Annemie Spooren
Prof. Annemie Spooren
Hasselt University