Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Maximum Inspiratory Pressure (PImax)
研究概览
简要总结
Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
详细描述
Spinal cord injury (SCI) is commonly associated with motor control deficits. When injury alters the control of trunk muscles, respiratory function is compromised leading to respiratory complications (including COVID19-related), one of the primary causes of morbidity and mortality in patients with chronic SCI. However, none of the respiratory rehabilitative modalities for this population have yet been proven to be clinically effective.
Previous work demonstrated that respiratory motor function can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. It have been found that these improvements are associated with respiratory motor and autonomic activity-based plasticity. However, due to low excitability of spinal networks below the injury, the effectiveness of this intervention is limited to the levels of functional capacity preserved after injury.
Epidural Stimulation (scES) can activate spinal networks below level of the spinal cord lesion. It was demonstrated that tonic scES at the lumbar level in individuals with SCI lead to voltage-dependent changes in breathing pattern and enhanced voluntary respiratory muscle activation below the injury level. Preliminary data collected for this proposal indicate that spinal cord stimulation can enhance the adaptive plasticity and provide amplified therapeutic effects when it is combined with respiratory training.
The objective of this study is to investigate the mechanisms of respiratory functional and respiratory motor responses to the scES as an important step toward the long-term goal of developing effective evidence-based rehabilitation strategies for patients with SCI. The central hypothesis is that scES raises the excitability of motor networks for respiration resulting in amplified use-dependent neural plasticity in response to the respiratory training. The rationale for the proposed study is to justify the development of a new direction in respiratory rehabilitation by using respiratory training in combination with electrical spinal cord stimulation.
The central hypothesis will be tested by pursuing the following two specific aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •At least 18 years old
- •Stable medical condition
- •Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
- •Sustained SCI at least 24 months prior to entering the study
- •At least 15%-deficit in pulmonary function outcomes
排除标准
- •Painful musculo-skeletal dysfunction
- •Unhealed fracture
- •Contracture
- •Pressure sore
- •Urinary tract infection that might interfere with respiratory training
- •Clinically significant depression
- •Psychiatric disorders
- •Ongoing drug abuse;
- •Major cardiovascular disease
- •Major pulmonary disease
- •Ventilator dependence
- •Major endocrine disorders
- •Malignancy
- •Marked obesity
- •Deep vein thrombosis
- •HIV/AIDS related illness
- •Secondary causes of respiratory dysfunction
- •Major gastrointestinal problems
- •Other major medical illness contraindicated for respiratory training
- •Pregnantcy
研究组 & 干预措施
Respiratory Training
Research subjects with no implanted stimulator undergoing RT intervention.
干预措施: Respiratory Training (Other)
Spinal Cord Stimulation
Research subjects with implanted stimulator undergoing stimulation intervention.
干预措施: Spinal Cord Epidural Stimulation (Device)
Spinal Cord Stimulation and Respiratory Training
Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.
干预措施: Spinal Cord Epidural Stimulation (Device)
Spinal Cord Stimulation and Respiratory Training
Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.
干预措施: Respiratory Training (Other)
结局指标
主要结局
Change in Maximum Inspiratory Pressure (PImax)
时间窗: Through study completion, an average of 1 year.
Standard Spirometry measurement.
Change in Maximum Expiratory Pressure (PEmax)
时间窗: Through study completion, an average of 1 year.
Standard Spirometry measurement.
Change in Surface electromyography (sEMG) Magnitude (Mag)
时间窗: Through study completion, an average of 1 year.
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Change in Surface electromyography (sEMG) Similarity Index (SI)
时间窗: Through study completion, an average of 1 year.
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
次要结局
- Change in Baroreflex Effectiveness Index (BEI)(Through study completion, an average of 1 year.)
- Change in Forced Vital Capacity (FVC)(Through study completion, an average of 1 year.)
- Change in Forced Expiratory Volume in 1 second (FEV1)(Through study completion, an average of 1 year.)
- Change in Baroreflex sensitivity (BRS)(Through study completion, an average of 1 year.)
研究者
Alexander V Ovechkin, MD, PhD
Associate Professor
University of Louisville