Spinal Cord Stimulation to Restore Cough
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hospital, Neurology, Orthopedic |
Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Orthopedics / Podiatry, Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/3/2018 |
Start Date: | September 30, 2004 |
End Date: | October 31, 2017 |
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.
an effective cough in patients with spinal cord injuries.
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.
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.
Inclusion Criteria:
- Stable spinal cord injury T5 level or higher
- Expiratory muscle weakness
Exclusion Criteria:
- Significant cardiovascular disease
- Active lung disease
- Brain disease
- Scoliosis, chest wall deformity, or marked obesity
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