Spinal Cord Stimulation 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 to produce
      an effective cough in patients with spinal cord injuries.
    

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. 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
      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 18 adults (18-70 years old) with spinal injuries (T5
      level or higher), at least 12 months following the date of injury. After an evaluation of
      medical history, a brief physical examination, and initial testing, participants will have
      small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of
      their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
    

Intervention name(s): Spinal Cord Stimulation to restore cough; Expiratory Muscle Stimulator
Intervention type(s): Procedure; Device
Intervention description(s): Participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the 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.
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