Clinical Trial

Abdominal Stimulation to Improve Cough After Spinal Cord Injury

Study acronym: COUFES
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn if abdominal functional electrical stimulation (FES) using the VentFree Respiratory Muscle Stimulator improves cough strength in adults with a new spinal cord injury (SCI). It will also learn about the safety of abdominal FES in this population. The main questions it aims to answer are: Does abdominal FES improve cough peak flow (a measure of cough strength) compared to cough training alone? Does abdominal FES reduce the number of respiratory complications (such as pneumonia or atelectasis)? What medical problems do participants have when receiving abdominal FES? Researchers will compare abdominal FES (active treatment) to supervised cough training without stimulation (control) to see if abdominal FES improves cough function after spinal cord injury. Participants will: Receive abdominal FES or perform supervised cough training 5 days per week for up to 6 weeks during inpatient rehabilitation Have cough strength and breathing function measured at the start of the study and every week during treatment Complete quality of life and bowel function questionnaires at multiple time points Have a follow-up visit or phone call 4 weeks after completing treatment
Trial Details
NCT Number NCT07626931
Lead Sponsor Liberate Medical
Collaborators: United States Department of Defense
Conditions Spinal Cord Injuries (SCI), Respiratory Insufficiency
Enrollment 150 participants
Start Date 2026-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-04