CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Spinal Cord Stimulation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00995215
NCT00995215N/ACompleted
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Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough

MetroHealth Medical Center·interventional·Posted Oct 15, 2009·Updated Apr 14, 2020

In Brief

A clinical study evaluating Spinal Cord Stimulation and Expiratory Muscle Stimulator for Spinal Cord Injuries and 4 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 15, 2017
Study CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 16.7 years ago

Interventions

Spinal Cord Stimulationprocedure

The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.

Expiratory Muscle Stimulatordevice

The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.