Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06019949

Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury

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

36

Participants Needed

1

Research Sites

343 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 complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our original respiratory training method. However, the effectiveness of this intervention is limited due to the disruption of brain-spinal connections and consequently lowered spinal cord activity below the injury level. Our recent studies showed that electrical stimulation of the spinal cord below the level of injury leads to increased ventilation which indicates activation of the spinal cord structures related to respiration. These findings indicate that spinal cord stimulation can be a promising therapeutic additive to the treatment. The goal of this study is to justify the establishment of a new direction in rehabilitation for patients with SCI by using a non-invasive spinal cord stimulation in combination with respiratory training. Our aims are: 1) to evaluate the effects of such stimulation applied to the injured spinal cord on pulmonary function and respiratory muscle activity, and 2) to evaluate the effectiveness and therapeutic mechanisms of the spinal cord stimulation combined with respiratory training. Thirty-six individuals with chronic SCI will be recruited and assigned to three groups to receive respiratory training or spinal cord stimulation alone or a combination of them. All participants will be tested before and after cycles of experimental procedures with/or without stimulation. Our hypotheses will be confirmed if the respiratory training combined with spinal cord stimulation results in the most enhanced positive effects.

CONDITIONS

Official Title

Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 (no negative change in neurological level or motor-completeness) at least 6 months prior to screening
  • Motor-complete spinal cord injury (AIS grade "A" or "B") above T5 spinal level
  • Spinal cord injury sustained at least 12 months before entering the study
  • At least 15% deficit in pulmonary function outcomes (FVC and FEV1) compared to healthy norms as detected by screening spirometry
Not Eligible

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 (including anemia, hypervolemia, endocrine, and neurological diseases)
  • Major esophageal/gastrointestinal problems or other major medical illnesses contraindicated for respiratory training or testing
  • Pregnancy or planning to become pregnant during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Andrea Willhite, MS

CONTACT

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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