CompletedNot Applicable

Stimulation With Wire Leads to Restore Cough

United States12 participantsStarted 2015-04

Plain-language summary

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Spinal cord injury C8 level or higher * 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (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

What they're measuring

Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.

Timeframe: 52 weeks (1 year)

Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough

Timeframe: 52 weeks (1 year)

Trial details

NCT IDNCT01659541

SponsorMetroHealth Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-31

Results submitted2022-05-18

View on ClinicalTrials.gov More Spinal Cord Injuries trials