Stimulation With Wire Leads to Restore Cough

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2021

Conditions
Spinal Cord InjuriesSpinal Cord DiseasesParalysisCentral Nervous System DiseasesCoughTrauma, Nervous SystemWounds and Injuries
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.

Trial Locations (1)

44109

MetroHealth Medical Center, Cleveland

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

MetroHealth Medical Center

OTHER

NCT01659541 - Stimulation With Wire Leads to Restore Cough | Biotech Hunter | Biotech Hunter