Combinatorial Treatment of Acute Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Improve Hand Function in People With Cervical Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Upper Extremity Function
研究概览
简要总结
The purpose of this study is to test the efficacy of mild breathing bouts of low oxygen (intermittent hypoxia) combined with transcutaneous electrical spinal cord stimulation on restoring hand function in persons with chronic incomplete spinal cord injury.
详细描述
The goal of this study is to determine the effectiveness of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with non-invasive transcutaneous electrical spinal cord stimulation (TESS) on restoring hand function in persons with chronic incomplete SCI.
The fundamental hypothesis guiding this proposal is that daily AIH+TESS engage excitatory and inhibitory pathways, which converge on a common plasticity-promoting cascade that induces greater recovery of hand function than either one alone.
Both treatments appear to enhance motor function in persons with cervical SCI. Despite their independent effects on promoting functional benefits, it is not yet know if they may promote greater functional benefits when combined. To be effective as a long-term rehabilitation strategy, it is essential to determine the efficacy of combined protocols of recurring AIH+TESS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old
- •medically stable with medical clearance from physician to participate
- •SCI at or below C3 and at or above C7
- •non-progressive etiology of spinal injury
- •American Spinal Injury Association Impairment Scale (AIS) C-D at initial screen
- •at least 1 year post-injury (chronic)
- •difficulty independently performing hand functions in activities of daily living
排除标准
- •dependence on ventilation support
- •implanted stimulator (e.g. diaphragm pacing by phrenic nerve stimulation, vagus nerve stimulator, pacemaker, cochlear implant, epidural stimulator, baclofen pump, etc.)
- •spinal cord injury related complications including unhealed pressure sore, severe neuropathic or chronic pain syndrome, history of frequent autonomic dysreflexia, infection (e.g. urinary tract), cardiovascular disease (e.g. deep vein thrombosis), pulmonary disease, heterotopic ossification in the upper extremities, severe osteoporosis, unhealed fracture, contracture of the upper extremity joints
- •received botulinum toxin injections in upper extremity muscles in the prior 6 months
- •history of tendon or nerve transfer surgery in the upper extremity
- •history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) or peripheral nerve injury in the upper extremity
- •history of concomitant diseases that would prevent full participation in intensive exercise therapy, such as uncontrolled hypertension, rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), pulmonary disease, active cancer, chronic contagious disease, etc.
- •anticoagulation medication
- •pregnancy
- •history of allergic reaction or any skin reaction to use of adhesive electrodes
结局指标
主要结局
Change in Upper Extremity Function
时间窗: Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)
Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.
Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand
时间窗: Once each intervention week (days 5, 10, and 15), and once at followup (week 8)
Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.
Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand
时间窗: Once each intervention week (days 5, 10, and 15), and once at followup (week 8)
Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.
次要结局
未报告次要终点
研究者
Randy Trumbower, PT, PhD
Assistant Professor
Spaulding Rehabilitation Hospital