Actively Recruiting
Neuromodulatory Rehabilitation for Respiratory Motor Function in Individuals With Chronic Spinal Cord Injury
Led by University of Louisville · Updated on 2026-03-13
36
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new rehabilitation methods to improve breathing in people with chronic spinal cord injury (SCI), a condition that often leads to serious respiratory problems. This study aims to assess the effects of non-invasive spinal cord stimulation combined with respiratory training, exploring how these treatments can enhance lung function and the activity of respiratory muscles. Thirty-six adults with stable, chronic SCI will participate to help establish this approach as a promising therapy for respiratory rehabilitation. Participants will be randomly assigned to one of three groups: respiratory training alone, spinal cord transcutaneous stimulation (scTS) alone, or a combination of both. The scTS uses a device that applies electrical stimulation through electrodes placed on the skin over the thoracic spine and other areas. Respiratory training involves exercises using devices that create resistance during breathing to strengthen respiratory muscles. Each participant will complete 80 sessions of their assigned intervention over 16 weeks, with careful monitoring of vital signs during stimulation. Throughout the study, participants will undergo assessments before and after the interventions, including measurements of maximum inspiratory and expiratory pressures and muscle activity via surface electromyography. Additional tests will evaluate lung function, heart rate, blood pressure responses, and independence in daily activities. Follow-up evaluations will continue for 32 weeks to monitor lasting effects. This thorough testing helps researchers understand how these therapies impact breathing and overall function in individuals with chronic SCI.
CONDITIONS
Brief Title
Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Stable medical condition
- No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with respiratory training or stimulation
- No clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Non-progressive spinal cord injury at or above the T5 spinal level, motor-complete SCI grade A or B according to ASIA Impairment Scale
- Sustained spinal cord injury at least 12 months before joining the study
- At least 15% deficit in pulmonary function (FVC and FEV1) compared to healthy population based on screening spirometry
You will not qualify if you...
- Major pulmonary or cardiovascular disease
- Ventilator dependence
- Endocrine disorders
- Malignancy
- Marked obesity
- Deep vein thrombosis
- HIV/AIDS-related illness
- Secondary hypotension due to anemia, hypervolemia, endocrine or neurological diseases
- Major esophageal, gastrointestinal, or other medical illness contraindicated for respiratory training or testing
- Pregnancy or planning to become pregnant during the study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo baseline evaluations of respiratory function and related measures before starting the intervention.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants receive one of three interventions: Respiratory Training alone, spinal cord Transcutaneous Stimulation alone, or a combination of both. The intervention consists of 80 sessions delivered over approximately 16 weeks, involving respiratory training and/or stimulation.
80 sessions over 16 weeks
Duration - 16 weeks
Participants are monitored for 16 weeks after completing the intervention to assess sustained effects on respiratory function.
Assessments within 2 weeks after intervention end and at 16 weeks post-intervention
Trial Site Locations
Total: 1 location
1
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Andrea Willhite, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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