Department of Physical Medicine and Rehabilitation, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio, USA.
Department of Research, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio, USA.
J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7.
To compare the safety and effectiveness of wire (WE) vs. disc (DE) electrodes to restore cough in subjects with spinal cord injury (SCI).
Clinical trials assessing the effectiveness and clinical outcomes associated with two electrode systems to activate the expiratory muscles.
Inpatient hospital setting for DE or WE electrode insertion; outpatient evaluation of cough efficacy and instructions for home use.
Twenty-nine subjects with SCI; 17 participants with DE and 12 with WE implants.
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.
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 cmHO and 118 ± 14 cmHO, 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.
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. ClinicalTrials.gov identifier: NCT00116337., NCT01659541, FDA IDE: G980267.
比较线（WE）与盘（DE）电极在脊髓损伤（SCI）患者中恢复咳嗽的安全性和有效性。
评估两种电极系统激活呼气肌的有效性和临床结果的临床试验。
在 DE 或 WE 电极插入的住院医院设置；门诊评估咳嗽效果并指导家庭使用。
29 名 SCI 患者；17 名 DE 参与者和 12 名 WE 植入物参与者。
手术植入 WE 或 DE 以恢复咳嗽。在家中每天应用脊髓刺激（SCS）。
SCS 产生的气道压力（P）和峰值气流（F）；包括排痰难易度、急性呼吸道感染（RTI）发生率和副作用在内的临床参数。
DE 和 WE 产生的 P 和 F 没有显著差异。例如，在总肺容量（TLC）下，参与者用力时，P 分别为 128 ± 12 cmHO 和 118 ± 14 cmHO。两组排痰困难程度均明显改善。每年 RTI 的发生率从 1.3 ± 0.3 和 1.3 ± 0.5 分别下降到 0.3 ± 0.1 和 0.1 ± 0.1（与植入前相比，两组均 P<0.01，两组之间无显著性差异）。唯一显著的副作用即短期自主神经反射障碍在两组之间也相似。
本研究结果表明，DE 和 WE 均可实现类似程度的呼气肌激活、临床获益和副作用。重要的是，使用 WE 可以实现恢复咳嗽的 SCS，使用微创技术可降低成本、手术时间和整体风险。临床试验注册号：NCT00116337，NCT01659541，FDA IDE：G980267。
