Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak Cough Flow
研究概览
简要总结
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.
详细描述
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.
Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.
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
- 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
- 是
入选标准
- •Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
- •History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
- •Between 14-60 days from date of injury at time of enrollment
- •Baseline PCF below 270 L/min
- •Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
- •Medically cleared by the participants primary inpatient physiatry attending physician
排除标准
- •Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
- •Individuals with contraindications to the interventions of interest:
- •TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
- •TSCS: Severe osteoporosis
- •Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
- •Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
- •Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol
结局指标
主要结局
Peak Cough Flow
时间窗: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device. The maximum number will be recorded.
Cough Partial Expiratory Flow Volume
时间窗: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements. The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.
次要结局
- Maximum inspiratory pressure(From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks)
- Changes in electromyography (EMG) of respiratory muscles(From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks)
- Maximum expiratory pressure(From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks)
- Forced expiratory volume(From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab