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

Spinal Cord Injuries Clinical Trial

Official title: Neuromodulatory Rehabilitation for Respiratory Motor Function in Individuals With Chronic Spinal Cord Injury

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is a respiratory rehabilitation-based clinical study consisting of physiologically and functionally relevant mapping of respiratory function that enhances our knowledge of neurophysiological modulation evoked by non-invasive spinal cord Transcutaneous Stimulation (scTS) and contributes to the development of the next generation of rehabilitative approaches. Following the screening process and recruiting, the research subjects will undergo the following procedures: Subjects (total n=36) will be randomly assigned to three groups and will undergo baseline assessments; evaluations before and after 80 sessions of specific intervention (Respiratory Training /RT/ alone, scTS alone, or RT in combination with scTS); and during 16 week-long follow up period. ;

Related Conditions & MeSH terms

• Respiration Disorders
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT06019949
• Study type: Interventional
• Source: University of Louisville
• Contact: Andrea Willhite, MS
• Phone: 1-502-581-8675
• Email: andrea.willhite@louisville.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2023
• Completion date: April 10, 2030