An Early Feasibility Study to Evaluate ISI-C in SCI Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Evaluate safety issues
研究概览
简要总结
This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs.
This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.
详细描述
Intel Corporation, Nuvectra 18. US FDA Regulated: Yes 19. US FDA Regulated Drug: No 20. US FDA Regulated Device: Yes 21. US FDA Investigational New Device (IND)/Investigational Device Exemption (IDE): Yes 22. Human Subjects Protection Review: Pending Review 23. Data Monitoring Committee: Yes 24. FDA Regulated Intervention: Yes
25. Brief Summary:
This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs.
This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface) that will be implanted.
26. Detailed Description:
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults (men or women) between the ages of 18 and 65 years old
- •Complete or Incomplete SCI with AIS grade of A or B between the levels of C7/T1 and T10 (level and degree of injury based on the international standards for neurological classification of SCI (ISNCSCI))
- •Focal area of SCI due to trauma
- •SCI date of injury > 1 year prior to enrollment
- •Completed prior SCI rehabilitation program
- •Ability to use both upper extremities to ambulate with a wheelchair or crutches
- •Distance between the conus medullaris and site of injury must be > 4 cm
- •The ability to participate in intensive physical therapy and research > 4 hours per day for 2 weeks
- •Must provide informed consent prior to study participation
排除标准
- •• Presence of co-existing lower extremity neuropathy or disorders of the cauda equina
- •Presence of non-traumatic spinal cord pathology
- •Significant cognitive impairment or decreased level of consciousness
- •Presence of an intrathecal baclofen or morphine pump
- •Presence of a cardiac defibrillator or pacemaker
- •Presence of a deep brain stimulator device
- •Patient who has any contraindication to having a MRI performed
- •Severe or disabling joint contractures in the lower extremities
- •Presence of hematologic disorder or medication related coagulopathy that would preclude surgery
- •Lower extremity congenital or acquired deformities
- •Women who are pregnant or who are unwilling to use contraception during the study period
- •Body mass index > 30
- •Cardiopulmonary comorbidities that preclude participation in intensive physical therapy
- •Known or suspected patient non-compliance during the study period and at follow up
- •Patient life expectancy < 12 months
- •Presence of patient comorbidities or spinal anatomy that would preclude participation in the study per investigators' recommendation
研究组 & 干预措施
SCI Patient
Complete or Incomplete Spinal Cord Injury (SCI) patients with Asia Impairment Score (AIS) of A or B between the levels of C7/T1 and T10
干预措施: Intelligent Spine Interface (Device)
结局指标
主要结局
Evaluate safety issues
时间窗: 8 months
Evaluate safety issues associated with the implantation and use of ISI technology i.e. frequency of device related adverse events
次要结局
- Neurological Outcome Measures(8 months)
- Functional Outcome Measures(8 months)