Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in Myelinated Axon Count
研究概览
简要总结
After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.
This study of ES in these patients will investigate:
i) nerve regeneration over long distances;
ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and
iii) changes in functional outcomes in a patient population with much less variability.
Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;
- •i) isolated unilateral facial nerve palsy and
- •ii) a functioning contralateral facial nerve.
排除标准
- •Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
- •Patients with severe cognitive impairment, which would limit their participation
结局指标
主要结局
Change in Myelinated Axon Count
时间窗: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.
Change in Pre-Operative Lip Excursion with Smile
时间窗: Change from Baseline (Pre-Op) over 2 Years
FACEGRAM will be used to objectively analyse change in commissure excursion.
次要结局
- Change in Facial Symmetry(Change from Baseline (Pre-Op) over 2 Years)
- Nerve Fibre Diameter(Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later)
- Myelin Thickness(Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later)
- Myelin Thickness/Fibre Diameter Ratio(Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later)
- Facial Clinimetric Evaluation (FaCE) Scores(Change from Baseline (Pre-Op) Over 2 Years)
- Time to Reinnervation(Up to 1 year after the Second Operation (FMT))
研究者
Gregory Borschel, MD
Principal Investigator
The Hospital for Sick Children