Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 18
- 主要终点
- Manual Motor Testing
研究概览
简要总结
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.
详细描述
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.
Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.
Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, inclusive
- •At least 3 months of non-operative rehab therapy
- •Mentally and physically willing and able to comply with evaluations
- •Less than 36 months post-injury
- •Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
- •ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- •EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
- •Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
- •Injury Level C4-C8
排除标准
- •Active infection at the operative site or systemic infection
- •Any return or ongoing clinical recovery of distal motor function
- •Mentally or physically compromised that will prevent them from complying with evaluations.
- •Immunologically suppressed
- •Currently undergoing long-term steroid therapy
- •Active malignancy
- •Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
- •Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
- •Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
结局指标
主要结局
Manual Motor Testing
时间窗: 48 months
Change from baseline testing strength of upper extremities at 48 months post-operatively
Handheld Dynamometry
时间窗: 48 months
Change from baseline grip strength at 48 months post-operatively
次要结局
- Rates of Intra-operative and post-operative complications(48 months)
- Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)(48 months)
- Change in Disabilities of Arm, Shoulder and Hand (DASH) scores(48 months)
- Change in Spinal Cord Injury Quality of Life (SCIQOL) scores(48 months)
- Neuro Quality of Life - Depression Short Form (NQOL-Dep)(48 months)
- Hand Function, measured by the GRASSP test(48 months)
- Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF)(48 Months)