Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
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
- Ankle Joint Torque
研究概览
简要总结
Transcutaneous (non-invasive) spinal cord stimulation (tSCS) has been shown to facilitate volitional motor activity in patients with spinal cord injury. tSCS is known to activate the same neural structures as invasive SCS, meaning it may have the potential for functional restoration without an expensive surgical implant. Functional electrical stimulation (FES) is also used in therapy for patients with spinal cord injury to locally activate paralyzed or weakened muscles. There is evidence that combining FES and tSCS may elicit greater muscle activation than either modality alone.
The objective of this study is to quantify the torque at the ankle joint generated by tSCS, by FES, and by tSCS + FES. Additionally, ultrasound images will be collected during stimulation to provide a metric of muscle activity. The correlation between ultrasound and torque will be assessed to determine if ultrasound is a useful modality for quantifying tSCS-elicited muscle activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 60 years of age
- •Weight less than 220 lb
- •Healthy and able to walk at preferred speed without an assistive device
- •Able to tolerate functional electrical stimulation and tSCS.
排除标准
- •Active infection
- •history of cancer,
- •broken skin, sores, or areas of acute eczema near the electrode sites
- •metal implants, such as staples or pins, near the electrode sites
- •any neurological disorders
- •difficulty walking or an orthopedic condition that would impede walking normally without assistance
- •absent sensation in the lower extremities or trunk (torso),
- •allergies to adhesive skin tapes and/or ultrasound gels,
- •heart conditions
- •an implanted electronic device such as a pacemaker
- •current pregnancy
- •having no physiological response to FES and/or tSCS.
研究组 & 干预措施
Subjects without Disability
Up to 30 participants with no disabilities will be recruited.
干预措施: Functional Electrical Stimulation (Device)
Subjects without Disability
Up to 30 participants with no disabilities will be recruited.
干预措施: Transcutaneous (Non-Invasive) Spinal Cord Stimulation (Device)
Subjects without Disability
Up to 30 participants with no disabilities will be recruited.
干预措施: Ultrasound (Device)
结局指标
主要结局
Ankle Joint Torque
时间窗: Through study completion, estimated 12 months
Ankle joint torque will be collected during stimulation with FES, with tSCS, and with FES + tSCS. We will compare the torque elicited by each simulation case.
Ultrasound-Derived Muscle Activation
时间窗: Through study completion, estimated 12 months
Ultrasound data will be collected from the shin muscles during FES, tSCS, and FES + tSCS. Muscle activation will be extracted from this data, and activation levels will be compared across stimulation cases.
次要结局
未报告次要终点
研究者
Nitin Sharma
Principal Investigator
North Carolina State University