Non-invasive Spinal Cord Stimulation Combined With Activity-based Rehabilitation in Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart)
研究概览
简要总结
Electrical spinal stimulation combined with activity-based rehabilitation (ABR) can improve motor and autonomic function in individuals suffering from varying degrees of paralysis. Spinal stimulation studies have included invasive implanted devices and non-invasive transcutaneous systems using different combinations of stimulation current, waveform, amplitude, duration and spinal levels targeted. Invasive and non-invasive systems have been demonstrated to permit individuals with chronic spinal cord injury (SCI), previously considered to have complete injuries on the International Standards for the Neurological Classification of Spinal Cord Injuries (ISNCSCI) scale (Classification A), to regain some degree of voluntary and autonomic function during periods of stimulation. The aim of this study is to evaluate the effects of a novel non-invasive transcutaneous electrical spinal cord stimulation system (tSCS) combined with activity-based rehabilitation in patients who have paralysis of their legs and/or arms. We will examine participants for any changes in sensory, motor or autonomic function. We will use a transcutaneous spinal cord stimulator that has been designed to deliver safe and tolerable bursts of high frequency pulsed current that minimise the capacitance efforts of the skin surface and maximise conductance of a second waveform using low frequency current to target neural structures. We aim to investigate this form of neuromodulation with a small group of individuals with chronic spinal cord injury. Our goal is to observe and describe any short term or lasting changes in function that can safely and comfortably be derived from this combination of spinal stimulation and activity-based rehabilitation. If this therapy can cause lasting improvements in sensory, motor, respiratory or autonomic function, then this may lead to a greater degree of functional independence for these individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Aged 18 years or over
- •Injury level C4-T12
- •At least one year post spinal cord injury
- •Medically stable and cognitively intact
- •Independent respiration, not requiring any ventilatory support
排除标准
- •Any active implanted metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators or drug delivery pump
- •Implanted surgical hardware that is not compatible with MRI scanners
- •Possible, suspected or confirmed pregnancy and/or lactation
- •Active Heterotopic Ossification
- •Recent history or fracture, contractures or pressure sore, deep vein thrombosis or urinary tract or other infection that may interfere with the intervention and training.
- •History of epilepsy and/or seizures.
- •Severe spasticity which have been unstable over the past 3 months prior to enrolment and not expected to change; taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and is not expected to change
- •Botulinum toxin injections within 6 months of participation (excluding bladder)
- •Non-injury related neurological impairment
- •Clinically significant severe depression in spite of treatment
- •Patients who have cardiovascular disease
- •Patients with Autonomic Dysreflexia that is severe, ongoing and has required medical treatment within the past one month
- •Active aggressive tumour within or surrounding the spinal cord or brain stem
- •A syrinx (fluid filled cavity) in the spinal cord
- •Skin conditions or allergies that may affect electrode placement
- •Bodyweight over 120kg (due to inability to use some of the study equipment)
- •Patients who do not understand English
结局指标
主要结局
International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart)
时间窗: 1 year
Sensory and motor scores. Sensory scale 0-224, motor scale 0-100 with higher scores relating to increased sensation and motor power
Spinal Cord Independence Measure (SCIM)
时间窗: 1 year
Functional independence tool for spinal cord injury. Scale of 0-100, with higher scores meaning increased function
Force dynamometry - hand
时间窗: 1 year
Grip and pinch strength using JTech force transducers. Measurements taken in Newtons
Berg Balance Score (where applicable)
时间窗: 1 year
Measure of standing balance. Scale of 0-56, with higher values meaning increased standing balance and reduced risk of falls
NeuroRecovery Scale (NRS)
时间窗: 1 year
Functional independence measure rated from 1a, the lowest classification of functioning to 4C, the highest classification of functioning
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Test
时间窗: 1 year
Upper limb measure of sensation and function. Strength scored 0-100, sensation scored 0-24 and prehension scored 0-64. Increased score relates to increased hand strength, sensation and function
Electromyography (EMG) of muscle activity
时间窗: 1 year
Upper limb, trunk and lower limb EMG using the Delsys Trigno System
Capabilities of Upper Extremity Questionnaire (CUE)
时间窗: 1 year
Upper limb capability questionnaire with 32 items. Scores between 32-124 with higher scores associated with higher levels of function of the upper limb
次要结局
- International Spinal Cord Society Autonomic Standards Assessment Form(1 year)
- World Health Organisation Quality Of Life - BREF (WHOQOL-BREF)(1 year)
- Modified Ashworth Scale(1 year)
- Respiratory function tests of maximal inspiratory and expiratory pressures(1 year)