A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Electromyography
研究概览
简要总结
The study seeks to improve the scientific understanding of how two electrical stimulation techniques, one which delivers electricity to the skin surface over the spine (transcutaneous electrical spinal stimulation [TESS]) and another which is implanted onto the dura mater of the spinal cord (epidural electrical stimulation [EES]), facilitate spinal circuitry to enable function after SCI.
详细描述
The study will compare motor activity and clinical outcomes over the course of TESS and EES in combination with physical rehabilitation.
The primary outcome data collected will be used to characterize and compare spinal sensorimotor activity in muscles below the level of injury during TESS and EES-enabled motor tasks in persons with chronic motor complete paralysis of the lower extremities due to traumatic SCI. Furthermore, data collected will be used as a proof of concept that TESS can be used to determine recovery of function during EES-enabled motor tasks. Following exposure to each stimulation intervention, data collection will include changes to spasticity, body composition, metabolic variables, and spinal imaging to assess the effect of either TESS or EES stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury due to trauma located between the seventh cervical (C7) and tenth thoracic vertebrae (T10)
- •American Spinal Injury Association grading scale of A or B (4 each of A and B) below the level of SCI
- •Intact spinal reflexes below the level of SCI
- •At least 1-year post-SCI
- •At least 22 years of age
- •Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
排除标准
- •Currently a prison inmate, or awaiting trial, related to criminal activity
- •Pregnancy at the time of enrollment
- •Dual energy x-ray absorptiometry (DEXA) t-score <-3.5 at spine and femur head
- •History of chronic and/or treatment resistant urinary tract infection
- •Unhealed decubitus ulcer
- •Unhealed skeletal fracture
- •Untreated clinical diagnosis of depression
- •Presence of joint contractures or an Ashworth spasticity score of 4
- •Active anti-spasticity medication regimen within 3 months prior to study enrollment
- •Presence of transcranial magnetic stimulation-evoked potentials in leg muscles
- •Undergoing, or planning to undergo, diathermy treatment
- •Active participation in another interventional clinical trial
- •Presence of conditions or disorders which require MRI monitoring
- •A history of coagulopathy or other significant cardiac or medical risk factors for surgery
- •Current use of a ventilator
- •Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
- •Mass > 113 kg (250 pounds)
- •History of frequent hypotension characterized by light headedness, or loss of consciousness
- •History of frequent hypertension characterized by headache, or bradycardia
- •History of frequent, severe, autonomic dysreflexia
- •Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
结局指标
主要结局
Electromyography
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of electrical activity at major muscle groups below the level of injury.
Kinematics
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of joint angles, measured in degrees.
Foot pressure
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of foot pressure through shoe-insole pressure sensors.
Overground ambulation [as appropriate to the subject] (1)
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Overground ambulation [as appropriate to the subject] (2)
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Measurement of changes in walking impairment as measured by the Walking Index for Spinal Cord Injury. Trainers will assess overall level of impairment, ranging from most severe impairment (0) to least severe impairment (20), based on the use of devices, braces, and physical assistance of one or more persons.
Somatosensory evoked potentials
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of change in conduction in the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, through surface electrodes.
Transcranial magnetic stimulation motor evoked potentials
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of stimulus intensity required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Monosynaptic spinal reflex testing
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Trunk stability
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of trunk stability using the modified functional reach test (mFRT).
Injury severity: American Spinal Injury Association (ASIA) Impairment Scale
时间窗: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of ASIA classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
次要结局
- Metabolics - HDL cholesterol(Baseline, End of TESS, Start of EES, End month 6 EES)
- Body composition - lean mass(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - glucose(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - total cholesterol(Baseline, End of TESS, Start of EES, End month 6 EES)
- Patient-reported bowel function (2)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Male patient-reported sexual function (1)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - CBC(Baseline, End of TESS, Start of EES, End month 6 EES)
- Spasticity(Baseline, End of TESS, Start of EES, End month 6 EES)
- Bone mineral density(Baseline, End of TESS, Start of EES, End month 6 EES)
- Body composition - body fat mass(Baseline, End of TESS, Start of EES, End month 6 EES)
- Body composition - android and gynoid fat percentage(Baseline, End of TESS, Start of EES, End month 6 EES)
- Body composition - bone mass(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - calculated LDL cholesterol(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - triglycerides(Baseline, End of TESS, Start of EES, End month 6 EES)
- Neurostimulator array location and migration(Start of EES, End month 6 EES)
- Patient-reported bladder function (2)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Male patient-reported sexual function (2)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Metabolics - non-HDL cholesterol(Baseline, End of TESS, Start of EES, End month 6 EES)
- Patient-reported bowel function (1)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Patient-reported bladder function (1)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Male patient-reported sexual function (3)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Female patient-reported sexual function (1)(Baseline, End of TESS, Start of EES, End month 6 EES)
- Female patient-reported sexual function (2)(Baseline, End of TESS, Start of EES, End month 6 EES)
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic