CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Expiratory muscle stimulator +1 moredevice
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/NCT01659541
NCT01659541N/ACompleted
CompareCT.gov

Spinal Cord Stimulation With Wire Leads to Restore Cough

MetroHealth Medical Center·interventional·Posted Aug 8, 2012·Updated Dec 8, 2022

In Brief

A clinical study evaluating Expiratory muscle stimulator and Implantation of device for Spinal Cord Injuries and 6 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2012
Enrollment StartApr 1, 2015
Primary CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.9 years ago

Interventions

Expiratory muscle stimulatordevice

The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord 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.

Implantation of deviceprocedure

The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads 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 to stimulate the expiratory muscles and restore cough.