Stimulation With Wire Leads to Restore Cough

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.

Inclusion Criteria:

- Spinal cord injury C8 level or higher

- 12 months post-injury (if AIS incomplete) or 6 months post-injury (if AIS complete)

- Expiratory muscle weakness

- Between 18 and 75 years of age

- Adequate oxygenation

Exclusion Criteria:

- Untreated lung, cardiovascular or brain disease

- Scoliosis, chest wall deformity, or marked obesity

- Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)

- Low oxygenation

- Minor infection at the site of implantation requiring antibiotics within the past 3
weeks

- Serious infection requiring hospitalization within the past 6 weeks