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Spinal Cord Stimulation to Restore Cough - Article


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Occult Spinal Dysraphism Sequence


Clinical Trial: Spinal Cord Stimulation to Restore Cough

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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.
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

Further Study Details: 

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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Stable spinal cord injury T5 level or higher
  • Expiratory muscle weakness

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00116337

Dana Hromyak, RRT      (216) 778-3612    dhromyak@metrohealth.org

Ohio
      MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Dana Hromyak, RRT  216-778-3612    dhromyak@metrohealth.org 
Anthony F. DiMarco, MD,  Principal Investigator

Study chairs or principal investigators

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.

Study ID Numbers:  R01NS049516
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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October 12, 2008



Page Updated: September 6, 2005
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