Sub-study to Spinal Cord Stimulation to Restore Cough
Condition: Spinal Cord Injuries; Spinal Cord Diseases; Paralysis; Central Nervous System Diseases; Cough
MeSH terms: Cough; Spinal Cord Injuries; Nervous System Diseases; Paralysis; Central Nervous System Diseases; Spinal Cord Diseases
Study type: Interventional

Summary: 
      Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
    

Detailed description: 
      Patients with cervical and thoracic spinal cord injuries often have paralysis of a major
      portion of their expiratory muscles - the muscles responsible for coughing - 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 the development of
      recurrent respiratory tract infections such as pneumonia and bronchitis. In fact, pneumonia
      is a major cause of death in this patient population.

      In a recent clinical trial, we have shown that the expiratory muscles can be electrically
      activated by spinal cord stimulation (SCS), a technique which involves the surgical placement
      of disc electrodes on the surface of the spinal cord. This method is successful in achieving
      an effective means of expiratory muscle activation, as demonstrated by the generation of
      large airway pressures and peak airflow rates. Importantly, SCS facilitates secretion
      removal, reduces the need for caregiver support, reduces the incidence of respiratory tract
      infections and improves life quality. This method therefore has the potential to reduce
      health care costs and improve survival in spinal cord injured subjects.

      The purpose of this trial is to directly compare activation of the expiratory muscles using
      wire electrodes, which can be inserted percutaneously through a needle, with the previously
      employed disc electrodes.

      In this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (T5
      level or higher), at least 12 months following the date of injury. After an evaluation
      including medical history, a brief physical examination, and initial testing, each
      participant will undergo a surgical procedure to implant small electrodes (metal discs) over
      the surface of the spinal cord on the lower back to stimulate the expiratory muscles and
      restore cough. Prior to permanent implantation of this system, wire and disc electrodes will
      be compared by assessing the degree of expiratory muscle activation with each electrode type.
      The disc electrodes will then be permanently implanted, allowing the participant to have use
      of a fully functioning stimulation system to restore an effective cough.
    

Intervention name(s): Spinal Cord Stimulation; Expiratory Muscle Stimulator
Intervention type(s): Procedure; Device
Intervention description(s): The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.; The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
Other intervention name(s): NeuroControl Expiratory Muscle Stimulation (IDE G980267)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; paralysis; cough; cervical spinal cord injury; thoracic spinal cord injury