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Spinal Cord Stimulation and Respiration After Injury

Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.

What is being tested

• Spinal Cord Epidural Stimulation (device)
• Respiratory Training (other)

Sponsor: University of Louisville · Participants: 30 · Started: Dec 31, 2021

Contact the study team

• Alexander Ovechkin, MD, PhD · Phone: 5025818675
• Andrea Willhite, MS · Phone: 5025818675

Official record on ClinicalTrials.gov — NCT05178056

Locations in the U.S.

Conditions

• Spinal Cord Injuries

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.