Stimulation With Wire Leads to Restore Cough
Condition: Spinal Cord Injuries; Spinal Cord Diseases; Paralysis; Central Nervous System Diseases; Cough; Trauma, Nervous System; Wounds and Injuries
MeSH terms: Cough; Spinal Cord Injuries; Nervous System Diseases; Paralysis; Central Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire
      leads, to produce an effective cough in patients with spinal cord injuries.
    

Detailed description: 
      Patients with cervical 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. Expiratory muscles can be
      activated by electrical stimulation of the spinal roots to produce a functionally effective
      cough.

      The purpose of this trial is to determine if electrical stimulation of the expiratory muscles
      by wire leads is capable of producing an effective cough on demand. According to the trial
      researchers, if successful, this technique will prevent the need for frequent patient
      suctioning - which often requires the constant presence of trained personnel. It will also
      allow spinal cord injured patients to clear their secretions more readily, thereby reducing
      the incidence of respiratory complications and associated illness and death.

      In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal
      injuries (C8 level or higher), at least 6 months following the date of injury. After an
      evaluation of medical history, a brief physical examination, and initial testing,
      participants will have wire leads placed - by a routine, minimally invasive surgical
      procedure - over the surface of their spinal cords on the lower back to stimulate the
      expiratory muscles and restore cough.
    

Intervention name(s): Expiratory muscle stimulator; Implantation of device
Intervention type(s): Device; Procedure
Intervention description(s): The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.; The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads 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 to stimulate the expiratory muscles and restore cough.
Other intervention name(s): Custom Finetech/Ardiem Sacral Anterior Root Stimulator
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