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NCT03364660 · ClinicalTrials.gov registry record · NA
Task-specific Epidural Stimulation Study
A NA study of Spinal Cord Injuries, sponsored by University of Louisville.
- Recruiting
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03364660 is a NA study of Spinal Cord Injuries 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
NCT03364660, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.
Conditions Studied
Interventions
- DEVICE Acute epidural stimulation for cardiovascular stability
- DEVICE Long Term Epidural Stimulation for Cardiovascular Stability
- DEVICE Participants undergo approximately 4 months of epidural stimulation for voluntary movement.
- DEVICE Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training
- DEVICE Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2024-12-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03364660
The ClinicalTrials.gov registry entry for NCT03364660 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 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 5 interventions - of which Acute epidural stimulation for cardiovascular stability is the first listed.
NCT03364660 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT03364660 about?
NCT03364660 is a clinical study titled "Task-specific Epidural Stimulation Study". The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascul...
What is the current status of trial NCT03364660?
This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2017-11-08. Estimated completion is 2024-12-30.
What conditions does trial NCT03364660 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03364660?
The interventions under investigation include: Acute epidural stimulation for cardiovascular stability (DEVICE), Long Term Epidural Stimulation for Cardiovascular Stability (DEVICE), Participants undergo approximately 4 months of epidural stimulation for voluntary movement. (DEVICE), Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training (DEVICE), Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training. (DEVICE).
Who is sponsoring clinical trial NCT03364660?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03364660 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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Related
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