Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Manual muscle testing (MMT)
研究概览
简要总结
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
详细描述
The study's goals involve understanding how transcutaneous stimulation affects motor deficits across three dimensions; weakness, coordination, and spasticity. This will be investigated by an electrophysiological characterization lower-extremity deficits, using TS to interrogate neuromotor topography and connectivity of the spinal cord to specific muscles. These evaluations will enable a unique patient-specific understanding of the electrophysiological mechanisms underlying motor deficits. Furthermore, these evaluations will assess the therapeutic potential of a novel closed-loop TS plasticity induction protocol to strengthen weakened muscles in a pediatric SB population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital diagnosis of myelomeningocele (MMC)
- •Able to follow verbal commands or instructions.
- •If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.
排除标准
- •Severe cognitive deficits demonstrating inability to communicate needs
- •Gaping, weeping, or unhealed open wounds at the site of electrode placement
- •Unhealed fractures on load bearing bones
- •History of osteoporosis
- •History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)
- •Pregnancy
- •History of seizure
- •Ongoing infections (currently being treated or are symptomatic)
- •Any illness or condition which, based on the research team's assessment, will compromise 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
Manual muscle testing (MMT)
时间窗: 1 to 12 visits (up to 6 weeks)
Measuring muscle strength and function using the Daniels and Worthingham's Muscle Grading Scale. A physical therapist will use a 5-point scale to manually test the 5 lower extremity muscles on each side, with 0 being no visible or palpable contraction, up to 5 being full range of motion against gravity with maximal resistance. The maximum total score would be 50.
Spasticity (1)
时间窗: 1 to 12 visits (up to 6 weeks)
Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone. MAS for 4 muscle groups in each leg will be reported.
Spasticity (2)
时间窗: 1 to 12 visits (up to 6 weeks)
Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with the first swing angle (FSA) degrees as the primary outcome. Fewer degrees on swing angle indicating greater spasticity.
Gait
时间窗: 1 to 12 visits (up to 6 weeks)
Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment.
Coordination
时间窗: 1 to 12 visits (up to 6 weeks)
Coordination will be reported with the Selective Control Assessment of the Lower Extremity (SCALE) total limb score for both right and left leg. Total score for each limb is 10, with a higher score indicating coordination closer to optimal.
次要结局
- Electromyography (EMG)(1 to 12 visits (up to 6 weeks))
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic