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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: Recruiting Phase 2 study of Spinal Cord Injuries, sponsored by United States Department of Defense.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators will measure the speed of walking and the time elapsed during 10 meter distance.
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 |
What NCT04782947 shows while recruiting
NCT04782947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04782947's enrollment target sits among peer trials
20 126th of 202 higher than 66 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
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