Spinal Cord Stimulation to Restore Cough In Humans

描述（由申请人提供）：颈、胸脊髓损伤患者的呼气肌大部分麻痹，因此缺乏正常的咳嗽机制。因此，大多数患者清除呼吸道分泌物的能力明显降低，这是导致反复呼吸道感染和肺不张以及随之而来的高发病率和死亡率的一个因素。由于大多数患者损伤水平以下的脊髓是完整的，脊髓的运动神经元和支配呼气肌的周围神经肌肉系统是完整的。因此，从理论上讲，这些肌肉可以被电激活，从而产生有效的咳嗽机制。最近的动物研究（在我们的实验室进行）表明，下胸脊髓刺激（SCS）可以激活大部分的呼气肌。通过这种方法，SCS导致产生正常咳嗽特征的大气道正压和呼气流量峰值。我们的假设是，下胸椎SCS应用于脊髓损伤患者时，也会引起全身呼气肌收缩，产生有效的咳嗽机制。我们计划将这项技术应用于脊髓损伤的患者，他们的呼气肌的主要部分瘫痪。更具体地说，我们将评估以下患者：a)高位颈脊髓损伤（C1- C4）并因此依赖呼吸机；b)低位颈脊髓损伤（C4- c8）患者，其中大多数患者由于隔膜功能正常而能够自主呼吸；c)胸脊髓损伤患者。NDI Medical LLC （Cleveland, Ohio）的呼气肌刺激器和NeuroControl Corp. （Cleveland， OH）的电极将通过SCS激活呼气肌。功能性电刺激的呼气肌应该能够产生一个有效的咳嗽机制，通过独立的病人控制，并避免需要频繁的病人吸痰，这往往需要训练有素的人员的持续存在。这种方法将提高患者的生活质量，因为更大的幸福感和更少的压力分泌物清除方法。此外，这项技术应该为脊髓损伤患者提供更容易清除分泌物的能力，从而减少呼吸并发症的发生率和相关的发病率和死亡率。

DESCRIPTION (provided by applicant): Patients with cervical and thoracic spinal cord injuries have paralysis of a major portion of their expiratory muscles and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to their development of recurrent respiratory tract infections and atelectasis and attendant high morbidity and mortality. Since the spinal cord below the level of injury is intact in most patients, the motoneurons of the spinal cord and peripheral neuromuscular system innervating the expiratory muscles are intact. These muscles, therefore, can theoretically be electrically activated to produce a functionally effective cough mechanism. Recent animal studies (performed in our laboratory) indicate that a major portion of the expiratory muscles can be activated by lower thoracic spinal cord stimulation (SCS). By this method, SCS results in the generation of large positive airway pressures and peak expiratory flow rates characteristic of a normal cough. It is our hypothesis that lower thoracic SCS, when applied in patients with spinal cord injury, will also result in generalized expiratory muscle contraction and produce an effective cough mechanism. We plan to apply this technique to patients with spinal cord injury who have paralysis of a major portion of their expiratory muscles. More specifically, we will evaluate patients with a) high cervical spinal cord injury (C1- C4) and consequently ventilator dependent, b) patients with low cervical spinal cord injury (C4-C8), most of whom are able to breathe spontaneously due to normal diaphragm function and, c) patients with thoracic spinal cord injury. The NDI Medical LLC (Cleveland, Ohio) expiratory muscle stimulator and NeuroControl Corp. (Cleveland, OH) electrodes will be employed to activate the expiratory muscles via SCS. Functional electrical stimulation of the expiratory muscles should be capable of producing an effective cough mechanism on demand via independent patient control and obviate the need for frequent patient suctioning which often requires the constant presence of trained personnel. This method will improve patient quality of life due to a greater sense of well being and less stressful method of secretion removal. Moreover, this technique should provide spinal cord injured patients the capacity to clear their secretions more readily and thereby reduce the incidence of respiratory complications and associated morbidity and mortality.