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NCT06019949 · ClinicalTrials.gov registry record · NA
Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
A NA study of Spinal Cord Injuries and Respiration Disorders, sponsored by University of Louisville.
- Recruiting
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06019949 is a NA study of Spinal Cord Injuries and Respiration Disorders that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 36 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06019949, a NA study of Spinal Cord Injuries and Respiration Disorders, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Transcutaneous spinal cord stimulator
- DEVICE Respiratory Training
Study Locations (1)
Kentucky
- Frazier Rehabilitation and Neuroscience Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-09-10 |
| Est. Completion | 2030-04-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06019949
The ClinicalTrials.gov registry entry for NCT06019949 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (41% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Transcutaneous spinal cord stimulator is the first listed.
NCT06019949 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT06019949 about?
NCT06019949 is a clinical study titled "Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury". 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...
What is the current status of trial NCT06019949?
This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2023-09-10. Estimated completion is 2030-04-10.
What conditions does trial NCT06019949 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Respiration Disorders.
What interventions are being tested in trial NCT06019949?
The interventions under investigation include: Transcutaneous spinal cord stimulator (DEVICE), Respiratory Training (DEVICE).
Who is sponsoring clinical trial NCT06019949?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06019949 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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