The Effectiveness of a New Treatment for Patients With Peripheral Nerve Injuries in the Upper Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in the sensory nerve action potential amplitude (uV) at 2 years .
研究概览
简要总结
The primary goal of this study is to quantify the functional deficits caused by injuries to the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible benefit of electrical stimulation of the injured nerve following surgery. The investigators will test whether electrical stimulation will improve hand function and nerve regeneration after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common. In severe cases, functional outcomes even with surgery remain poor. Recently, electrical stimulation has been applied to injured nerves in rats. This was shown to improve nerve regeneration. These studies showed that as little as one hour of electrical stimulation was effective. Therefore, the investigators plan to test this new method of treatment to determine whether it is also helpful in humans. These will be done by using a symptom severity questionnaire, nerve conduction studies and by testing pressure sensations, hand dexterity and strength. The patients will be randomized to either the treatment or control group. Following the treatment, all baseline measurements will be reevaluated every three months for the first year and every 6 months during the second year. The timing and nature of the evaluation process will be identical in both groups.
详细描述
Background Rationale:
Surgical repair and nerve grafting are currently the standard treatment for nerve laceration. However, even with that, the functional outcome in patients with proximal nerve cut is often poor. In those cases, the surviving axons in the proximal nerve stump have already reached their capacity limit to sprout and to reinnervate. Therefore, no further reinnervation can occur even with surgery unless regeneration and extension of the proximal stump can somehow be enhanced. Unfortunately, although many attempts, none were shown to be effective in the clinical setting.
Post-surgical electrical stimulation:
Recent studies demonstrated that electrical stimulation applied directly to an injured peripheral nerve resulted in marked improvement of nerve regeneration. Preliminary data suggesting that electrical nerve stimulation could possibly enhance nerve regeneration has in fact been known for some time. Accelerated rate of regeneration was found in animals that received electrical stimulation for as little as 1 hour. Furthermore, preferential growth of the regenerating sensory axons into the appropriate nerve branch was also accelerated with electrical stimulation.
Since these studies showed that as little as one hour of electrical stimulation was effective in accelerating nerve regeneration, it opens the possibility of applying this to humans. The intervention is safe and of minimal discomfort. Furthermore, the use of electrical stimulation as a clinical treatment modality is already well accepted. In a recent study, the investigators applied this to patients with severe median nerve compressive injury in the carpal tunnel following surgery. The procedure was well tolerated with no adverse event observed in any of the 21 subjects after 1 year of follow up. In fact, compared to the control subjects who received surgery alone, those in the treatment groups showed quicker resolution of their symptoms and more vigorous motor nerve regeneration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe injury to the brachial plexus causing complete denervation.
排除标准
- •The presence of other neurologic conditions.
- •Cognitive compromise that renders the patients unable to understand and consent to the study.
- •Minors younger than the age of 18.
研究组 & 干预措施
Post surgical electrical stimulation
Balanced AC pulse at 20 Hz with less than 30V and 0.01 ms duration will be delivered for 1 hour.
干预措施: Post surgical electrical stimulation (Procedure)
Sham stimulation
Stimulation with the same parameters delivered only for 5 s.
干预措施: Post surgical electrical stimulation (Procedure)
结局指标
主要结局
Change in the sensory nerve action potential amplitude (uV) at 2 years .
时间窗: preop, every 3 to 6 months for 2 years
次要结局
- Change in the compound muscle action potential amplitude (mV) at 2 years(preop, every 3 to 6 months for 2 years)
- Change in the motor unit number estimation at 2 years(preop, every 3 to 6 months for 2 years)
- Change in the ability to perform hand function at 2 years.(preop, every 3 to 6 months for 2 years)