Actively Recruiting
Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury
Led by University of Louisville · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
200 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
Respiratory motor control problems are a main cause of illness and death in people with spinal cord injuries (SCI). This research aims to develop better breathing rehabilitation methods for those with chronic SCI by studying how epidural spinal cord stimulation (scES) affects breathing. The study will test if scES, alone or combined with respiratory training, can improve respiratory muscle control and function, focusing on those with injuries at the C3-T1 spinal cord level who have had SCI for at least 24 months. Participants will be divided into three groups: one receiving respiratory training only, one with an implanted spinal cord stimulator receiving stimulation only, and one receiving both stimulation and respiratory training. Respiratory training involves eighty 45-minute sessions over 16 weeks using devices that create inspiratory and expiratory pressure loads. The spinal cord stimulation is delivered via an implanted multi-electrode array placed epidurally over the spinal cord. The study will evaluate the immediate effects of stimulation and the longer-term benefits of combined therapy. During the study, participants will undergo assessments including pulmonary function tests, surface electromyography of respiratory muscles, trunk movement analysis, and cardiovascular monitoring like blood pressure and heart rate variability. These measures will be taken before, during, and after interventions, with follow-ups extending through about one year. Researchers will track changes in respiratory pressures, muscle activation patterns, lung capacity, and baroreflex sensitivity to understand treatment impact and safety throughout the study period.
CONDITIONS
Brief Title
Spinal Cord Stimulation and Respiration After Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Stable medical condition
- Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
- Sustained SCI at least 24 months prior to entering the study
- At least 15%-deficit in pulmonary function outcomes
You will not qualify if you...
- Painful musculo-skeletal dysfunction
- Unhealed fracture
- Contracture
- Pressure sore
- Urinary tract infection that might interfere with respiratory training
- Clinically significant depression
- Psychiatric disorders
- Ongoing drug abuse
- Major cardiovascular disease
- Major pulmonary disease
- Ventilator dependence
- Major endocrine disorders
- Malignancy
- Marked obesity
- Deep vein thrombosis
- HIV/AIDS related illness
- Secondary causes of respiratory dysfunction
- Major gastrointestinal problems
- Other major medical illness contraindicated for respiratory training
- Pregnantcy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants with an implanted spinal cord stimulator receive epidural spinal cord stimulation targeting respiratory motor networks.
Epidural stimulation applied during respiratory training sessions over 16 weeks
Duration - 16 weeks
Participants undergo respiratory training sessions using inspiratory and expiratory pressure threshold devices to improve respiratory function.
Eighty 45-minute sessions during 16 weeks
Duration - 16 weeks
Participants receive combined spinal cord stimulation and respiratory training to enhance respiratory motor function through use-dependent neural plasticity.
Eighty 45-minute sessions with concurrent epidural stimulation during 16 weeks
Duration - Up to 1 year
Participants are followed for up to 1 year to assess changes in respiratory function and motor control after intervention completion.
Periodic follow-up visits during the year after intervention
Trial Site Locations
Total: 1 location
1
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Alexander Ovechkin, MD, PhD
A
Andrea Willhite, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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