Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05178056

Spinal Cord Stimulation and Respiration After Injury

Led by University of Louisville · Updated on 2026-03-13

30

Participants Needed

1

Research Sites

469 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 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.

CONDITIONS

Official Title

Spinal Cord Stimulation and Respiration After Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Stable medical condition
  • Non-progressive C3-T1 AIS A-C Spinal Cord Injury
  • Injury sustained at least 24 months before study entry
  • At least 15% deficit in pulmonary function outcomes
Not Eligible

You will not qualify if you...

  • Painful musculo-skeletal dysfunction
  • Unhealed fracture
  • Contracture
  • Pressure sore
  • Urinary tract infection interfering 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
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, United States, 40202

Actively Recruiting

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Research Team

A

Alexander Ovechkin, MD, PhD

CONTACT

A

Andrea Willhite, MS

CONTACT

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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Spinal Cord Stimulation and Respiration After Injury | DecenTrialz