CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Spinal Cord Stimulation to restore cough +1 moreprocedure
Likely dose
Spinal cord stimulation via implanted electrodes over lower back to stimulate expiratory musclesAI-extracted
Key inclusion· 2
  • ✓Stable spinal cord injury at T5 level or higher
  • ✓Expiratory muscle weakness
Key exclusion· 4
  • ✕Significant cardiovascular disease
  • ✕Active lung disease
  • ✕Brain disease
  • ✕Scoliosis, chest wall deformity, or marked obesity

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

Search/NCT00116337
NCT00116337N/ACompleted
CompareCT.gov

Spinal Cord Stimulation to Restore Cough

MetroHealth Medical Center·interventional·Posted Jun 29, 2005·Updated May 4, 2020

In Brief

A clinical study evaluating Spinal Cord Stimulation to restore cough and Expiratory Muscle Stimulator for Spinal Cord Injuries and 6 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed Summary

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.

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
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2005
Enrollment StartSep 30, 2004
Primary CompletionOct 10, 2017
Study CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 21.0 years ago

Interventions

Spinal Cord Stimulation to restore coughprocedure

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. These electrodes are then activated at subsequent study visits using the 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.