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NCT04241250 · ClinicalTrials.gov registry record · Phase 2
Neuromodulation Techniques After SCI
A Phase 2 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04241250 is a Phase 2 study of Spinal Cord Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 4 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04241250, a Phase 2 study of Spinal Cord Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.
Conditions Studied
Interventions
- DEVICE EAW+SCES (exoskelton and spinal cord epidural stimulation)
- DEVICE EAW+TS (exoskelton and transspinal stimulation)
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04241250
The ClinicalTrials.gov registry entry for NCT04241250 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (95% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which EAW+SCES (exoskelton and spinal cord epidural stimulation) is the first listed.
NCT04241250 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT04241250 about?
NCT04241250 is a clinical study titled "Neuromodulation Techniques After SCI". Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to fac...
What is the current status of trial NCT04241250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2020-06-01. Estimated completion is 2024-12-31.
What conditions does trial NCT04241250 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT04241250?
The interventions under investigation include: EAW+SCES (exoskelton and spinal cord epidural stimulation) (DEVICE), EAW+TS (exoskelton and transspinal stimulation) (DEVICE).
Who is sponsoring clinical trial NCT04241250?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04241250 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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