Task-specific Epidural Stimulation Study
Public ClinicalTrials.gov record NCT03364660. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03364660
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- 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
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2017
- Primary completion
- Dec 29, 2024
- Completion
- Dec 29, 2024
- Last update posted
- Aug 27, 2024
2017 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03364660, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03364660 live on ClinicalTrials.gov.