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Stimulation With Wire Leads to Restore Cough

NCT01659541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-08

Study results available
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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.

Conditions

Interventions

DEVICE

Expiratory muscle stimulator

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.

PROCEDURE

Implantation of device

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Anthony F. DiMarco, MD · MetroHealth Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659541 on ClinicalTrials.gov