Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Range of Motion
研究概览
简要总结
In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be
- either processed in the Activa PC+S; or
- off-loaded via the Nexus D communication device (Medtronic) to a computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
Participants will be undergoing a unilateral implantation of the Medtronic Active PC+S with unilateral subdural strip electrodes over the motor cortex. They will receive 24 sessions over a 3-6 month period which consists of external stimulation.
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIS Grades A & B
- •Level of Injury C5 or C6
- •Local Community dwelling
- •Stable chronic injury
- •Stable health status and upper extremities
- •Completion of Clinical Protocol 01
排除标准
- •Coagulopathy
- •Anticoagulation
- •Pregnancy
研究组 & 干预措施
Medtronic Activa PC+S
Objective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by;
- Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level).
- Assessing the feasibility of activating fundamental upper extremity muscles to reproduce hand grasp.
These are important first steps towards creating and designing a device that can enhance or assist in performing activities of daily living (ADL) in the life of these subjects. Attachment 15.3
干预措施: Medtronic Activa PC+S (Device)
结局指标
主要结局
Range of Motion
时间窗: Up to 2 years
Joint Range of Motion for both active and passive for Flexion and extension
SCIM III (Spinal Cord Independence Measure)
时间窗: Up to 2 years
Self-report independence for daily activities of living scored from 1-6
AIS Sensory Score
时间窗: Up to 2 years
AIS Sensory scores has a score totaling 0-56 points for light touch and pin prick modalities for a total of a maximum of 112 points per side of the body. The lower scores indicate greater sensory impairment.
AIS Motor Score
时间窗: Up to 2 years
American Spinal Injury Association (ASIA) Impairment Scale (AIS) Motor scores has a score totaling 0-50 for the upper limbs and 0-50 for the lower limbs with the lower score indicating greater motor impairment
SF-36 scores
时间窗: Up to 2 years
Short Form 36 (SF-36) is a 36 item self-report health questionnaire
Modified Ashworth Scale
时间窗: Up to 2 years
Muscle tone scored during stretch from 0 to 5
Muscle Force Test
时间窗: Up to 2 years
0. No movement;1.Palpable contraction, no visible movement; 2. Movement but only with gravity eliminated; 3. Movement against gravity; 4. Movement against resistance but weaker than normal; 5. Normal power
JTT Hand Function Test
时间窗: Up to 2 years
Functional timed activities such as hand writing, page turning, lifting small objects, feeding, stacking checkers, lifting light cans and lifting heavy cans
Pinch Grip Strength
时间窗: Up to 2 years
Measurement of grip strength throughout training
次要结局
未报告次要终点
研究者
Jonathan Jagid
Associate Professor of Neurological Surgery
University of Miami