Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 19
- 主要终点
- Motor strength in medical research council grade (MRC)
研究概览
简要总结
The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.
Participants will:
- undergo standard of care pre- and post-op testing and study exams
- complete pre- and post-questionnaires
- undergo standard of care nerve transfer surgeries
- follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
- attend therapy at local therapist for up to 2 years postop.
详细描述
Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia.
One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies.
The two objectives of this study are:
- Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients.
- Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia.
Study Activities (including standard of care (SOC))
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •High cervical SCI (motor level C1-C4)
- •Motor complete SCI AIS grade A-B
- •Plateaued spontaneous recovery for at least 6 months of non-operative therapy
- •SCI greater than 6 months and fewer than 60 months since injury
- •At least MRC 4/5 donor strength
- •Mentally and physically willing and able to comply with evaluations
排除标准
- •Active infection at the operative site or systemic infection
- •Any return or ongoing recovery of distal motor function
- •Significant joint contractures and/or limitations in passive range of motion in the arm
- •Mentally or physically compromised making it impossible to complete study activities
- •Immunologically suppressed
- •Currently undergoing long-term steroid therapy
- •Active malignancy
- •Pregnancy
结局指标
主要结局
Motor strength in medical research council grade (MRC)
时间窗: 36-48 months post-surgery
Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score.
Elbow Dynamometry
时间窗: 36-48 months post-surgery
Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer
Spinal Cord Independence Measure
时间窗: 36-48 months post-surgery
Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors/outdoors). SCIM guide clinicians in determining treatment goals/objectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function.
Electrodiagnosis (Nerve Conduction Study and Electromyography
时间窗: 36-48 months post-surgery
Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.
次要结局
- Modified Ashworth Scale (MAS)(36-48 Months post-surgery)
- Canadian Outcomes Performance Measure (COPM)(36-48 Months post-surgery)
- Capabilities of Upper Extremity Questionnaire (CUE-Q)(36-48 Months post-surgery)
- Spinal Cord Injury Quality of LIfe Questionnaire(36-48 Months post-surgery)
- International SCI Pain Basic Dataset (ISCIPBDS)(36-48 Months post-surgery)
研究者
Wilson Z. Ray
MD - Principal Investigator
Washington University School of Medicine