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NCT04782947 · ClinicalTrials.gov registry record · Phase 2
Epidural Stimulation and Resistance Training After SCI
A Phase 2 study of Spinal Cord Injuries, sponsored by United States Department of Defense.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04782947 is a Phase 2 study of Spinal Cord Injuries that is actively recruiting participants, run by United States Department of Defense. The registered enrollment target is 20 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04782947, a Phase 2 study of Spinal Cord Injuries, is actively recruiting participants, sponsored by United States Department of Defense.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.
Conditions Studied
Interventions
- DEVICE Exoskeletal assisted walking
- DEVICE Epidural Stimulation
- PROCEDURE Resistance Training
- DEVICE delayed-ES
- PROCEDURE no-Resistance training
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04782947
The ClinicalTrials.gov registry entry for NCT04782947 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 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 (67% lower). The listed sponsor is United States Department of Defense, which has 13 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 Exoskeletal assisted walking is the first listed.
NCT04782947 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT04782947 about?
NCT04782947 is a clinical study titled "Epidural Stimulation and Resistance Training After SCI". Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people wi...
What is the current status of trial NCT04782947?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-02-03. Estimated completion is 2026-05-31.
What conditions does trial NCT04782947 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT04782947?
The interventions under investigation include: Exoskeletal assisted walking (DEVICE), Epidural Stimulation (DEVICE), Resistance Training (PROCEDURE), delayed-ES (DEVICE), no-Resistance training (PROCEDURE).
Who is sponsoring clinical trial NCT04782947?
This trial is sponsored by United States Department of Defense, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04782947 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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