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Epidural Stimulation After Spinal Cord Injury

NCT04105296 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-10-03

No results posted yet for this study

Summary

The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with chronic motor complete (AIS A or B) SCI and level of injury below C5 . Walking speed, distance, muscle activation pattern as measured by surface EMG and walking parameters including stand-up time, walking time, distance will be considered primary outcome variables. Cardiovascular performance, as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments will also be measured. The effects of training (ES+EKSO) on , and speed of walking will also be evaluated.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

EKSO+ES

6 months of exoskeleton training with epidural stimulation.

Sponsors & Collaborators

  • McGuire Research Institute

    lead OTHER

Principal Investigators

  • Ashraf S Gorgey, PhD · Hunter Holmes McGuire VA Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04105296 on ClinicalTrials.gov