Objective

To compare the safety and effectiveness of wire (WE) vs. disc (DE) electrodes to restore cough in subjects with spinal cord injury (SCI).

Design

Clinical trials assessing the effectiveness and clinical outcomes associated with two electrode systems to activate the expiratory muscles.

Setting

Inpatient hospital setting for DE or WE electrode insertion; outpatient evaluation of cough efficacy and instructions for home use.

Participants

Twenty-nine subjects with SCI; 17 participants with DE and 12 with WE implants.

Intervention

Surgical implantation of WE or DE to restore cough. Daily application of spinal cord stimulation (SCS) at home.

Main outcome measure(s)

Airway pressure (P) and peak airflow (F) generation achieved with SCS; clinical parameters including ease in raising secretions, incidence of acute respiratory tract infections (RTI) and side effects.

Results

P and F achieved with DE and WE were not significantly different. For example, at total lung capacity (TLC) with participant effort, P was 128 ± 12 cmH₂O and 118 ± 14 cmH₂O, with DE and WE, respectively. The degree of difficulty in raising secretions improved markedly in both groups. The incidence of RTI per year fell from 1.3 ± 0.3 and 1.3 ± 0.5–0.3 ± 0.1 and 0.1 ± 0.1 for DE and WE groups, respectively (P < 0.01 for both when compared to pre-implant values and NS between DE and WE groups). The only significant side effect i.e. short-term autonomic dysreflexia was also similar between groups.

Conclusions

The results of this investigation indicate that both DE and WE result in comparable degrees of expiratory muscle activation, clinical benefits and side effects. Importantly, SCS to restore cough can be achieved with use of WE which can be placed using minimally invasive techniques and associated reduction in cost, surgical time and overall risk.

Trial registration: ClinicalTrials.gov identifier: NCT00116337., NCT01659541, FDA IDE: G980267

中文翻译：

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圆盘电极和线电极通过下胸段脊髓刺激恢复咳嗽的比较

 客观的

比较线状 (WE) 电极与盘状 (DE) 电极恢复脊髓损伤 (SCI) 受试者咳嗽的安全性和有效性。

 设计

临床试验评估与两个电极系统激活呼气肌相关的有效性和临床结果。

 环境

用于 DE 或 WE 电极插入的住院医院环境；门诊咳嗽疗效评估和家庭使用说明。

 参加者

SCI 科目 29 项； 17 名参与者使用 DE 植入物，12 名参与者使用 WE 植入物。

 干涉

手术植入 WE 或 DE 以恢复咳嗽。每天在家应用脊髓刺激（SCS）。

 主要观察指标）

通过 SCS 实现气道压力 (P) 和峰值气流 (F) 生成；临床参数包括分泌物增加的容易程度、急性呼吸道感染（RTI）的发生率和副作用。

 结果

DE 和 WE 获得的 P 和 F 没有显着差异。例如，在参与者努力的总肺活量 (TLC) 下，DE 和 WE 的 P 分别为 128 ± 12 cmH ₂ O 和 118 ± 14 cmH ₂ O。两组的分泌物分泌困难程度均显着改善。 DE 组和 WE 组每年 RTI 的发生率分别从 1.3 ± 0.3 和 1.3 ± 0.5 下降到 0.3 ± 0.1 和 0.1 ± 0.1（P 与植入前值和 DE 组和 WE 组之间的 NS 相比，两者均 < 0.01）。唯一显着的副作用，即短期自主神经反射异常，在各组之间也相似。

 结论

这项研究的结果表明，DE 和 WE 都会产生相当程度的呼气肌激活、临床益处和副作用。重要的是，可以通过使用 WE 来实现 SCS 恢复咳嗽，WE 可以使用微创技术进行放置，从而降低成本、手术时间和总体风险。

试用注册： ClinicalTrials.gov 标识符：NCT00116337。 ，NCT01659541，FDA IDE：G980267