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Spinal Cord Stimulation and Breathing After Injury

This study is investigating a new way to improve breathing for people with spinal cord injuries. It combines Spinal Cord Epidural Stimulation (scES), which uses a small device implanted near the spinal cord, with Respiratory Training using special breathing devices. Researchers want to see if this combination can help strengthen your breathing muscles. To join, you need to be at least 18 years old, have a stable spinal cord injury (C3-T1 AIS A-C) that happened at least two years ago, and have at least a 15% deficit in your lung function. The study aims to measure changes in your breathing strength and muscle activity over about one year. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 30 participants. The phase of the study is not specified.
What's involved
You would participate in eighty 45-minute respiratory training sessions over 16 weeks, using a Positive Expiratory Pressure Device and an Inspiratory Muscle Trainer. Spinal Cord Epidural Stimulation will be administered via an implanted device.
Compensation
Not stated in the trial record.
Follow-up
Your breathing strength and muscle activity will be measured throughout the study, for an average of one year.

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NCT05178056

Spinal Cord Stimulation and Respiration After Injury

Recruiting
NAAges 18+Interventional
University of Louisville
~30 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Spinal Cord Epidural StimulationRespiratory Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Maximum Expiratory Pressure (PEmax)
Measured over Through study completion, an average of 1 year.
+3 more outcomes measured

Conditions

Spinal Cord Injuries
Spinal Cord Stimulation
Breathing Exercises
Rehabilitation

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Alexander Ovechkin, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Alexander Ovechkin, MD, PhD
[email protected]
5025818675
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in Maximum Expiratory Pressure (PEmax)Through study completion, an average of 1 year.

    Standard Spirometry measurement.

  • Change in Surface electromyography (sEMG) Magnitude (Mag)Through study completion, an average of 1 year.

    Respiratory multi-muscle activation measures assessed using standard surface electromyography.

  • Change in Surface electromyography (sEMG) Similarity Index (SI)Through study completion, an average of 1 year.

    Respiratory multi-muscle activation measures assessed using standard surface electromyography.

  • Change in Maximum Inspiratory Pressure (PImax)Through study completion, an average of 1 year.

    Standard Spirometry measurement.