NCT01997125已完成不适用
Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia
Marcia Bockbrader2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants With Voluntary Movement
研究概览
简要总结
The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.
详细描述
This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.
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
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 21 years or older.
- •Must be tetraplegic (C4- C6 ASIA A).
- •12 months post injury and neurologically stable.
- •Participant is willing to comply with all follow-up evaluations at the specified times.
- •Participant is able to provide informed consent prior to enrollment in the study.
- •The participant is fluent in English.
- •Participant must have a caregiver willing to participate in the study who will provide care for the surgical site.
排除标准
- •No active wound healing or skin breakdown issues.
- •No history of poorly controlled autonomic dysreflexia.
- •Medical contraindications for general anesthesia, craniotomy, or surgery.
- •Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- •Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI.
- •History of psychiatric disturbance or dementia
- •Other implantable devices such as heart/brain pacemakers
- •Participants who rely on ventilators
- •Co-morbid conditions that would interfere with study activities or response to treatment.
- •History of a neurological ablation procedure.
- •Labeled contraindication for MRI.
- •History of hemorrhagic stroke.
- •History of HIV infection or ongoing chronic infection (such as tuberculosis).
- •Pregnant or of child-bearing potential and are not taking acceptable methods of contraception.
- •Participation in another FDA device or medication trial that would interfere with the current study.
结局指标
主要结局
Number of Participants With Voluntary Movement
时间窗: 9 months
The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system
次要结局
未报告次要终点
研究者
Marcia Bockbrader
MD, PhD
Ohio State University
研究点 (2)
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