Occult Spinal Dysraphism Sequence |
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Clinical Trial: Spinal Cord Stimulation to Restore Cough
This study is currently recruiting patients.
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Spinal Cord Injury | Procedure: spinal cord stimulation | Phase I |
MedlinePlus related topics: Spinal Cord Injuries
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Expected Total Enrollment: 18
Study start: September 2004
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 (18-65 years old) with spinal injuries (T5 level or higher), at least 18 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.
Eligibility
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 obesity
Location and Contact Information
Ohio
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Anthony F. DiMarco, MD, Principal Investigator
Anthony F. DiMarco, MD, Principal Investigator, MetroHealth Medical Center
More Information
Publications
DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71.
DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol. 1999 Jun;86(6):1881-9.
DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol. 1999 Oct;87(4):1433-9.
DiMarco AF, Kowalski KE, Supinski G, Romaniuk JR. Mechanism of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol. 2002 Jun;92(6):2341-6.
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 28, 2005
ClinicalTrials.gov Identifier: NCT00116337
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05

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