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NCT05178056 · ClinicalTrials.gov registry record · NA
Spinal Cord Stimulation and Respiration After Injury
A NA study of Spinal Cord Injuries and Rehabilitation, sponsored by University of Louisville.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05178056 is a NA study of Spinal Cord Injuries and Rehabilitation that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 30 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05178056, a NA study of Spinal Cord Injuries and Rehabilitation, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DEVICE Spinal Cord Epidural Stimulation
- OTHER Respiratory Training
Study Locations (1)
Kentucky
- Frazier Rehabilitation and Neuroscience Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-31 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05178056
The ClinicalTrials.gov registry entry for NCT05178056 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 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 (51% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Spinal Cord Epidural Stimulation is the first listed.
NCT05178056 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT05178056 about?
NCT05178056 is a clinical study titled "Spinal Cord Stimulation and Respiration After Injury". 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 i...
What is the current status of trial NCT05178056?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2021-12-31. Estimated completion is 2030-12-31.
What conditions does trial NCT05178056 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Rehabilitation, Spinal Cord Stimulation, Breathing Exercises.
What interventions are being tested in trial NCT05178056?
The interventions under investigation include: Spinal Cord Epidural Stimulation (DEVICE), Respiratory Training (OTHER).
Who is sponsoring clinical trial NCT05178056?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05178056 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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