CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
EAW+SCES (exoskelton and spinal cord epidural stimulation) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04241250
NCT04241250Phase 2Completed

Transspinal Versus Epidural Stimulation for Exoskeletal Assisted Walking After Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Jan 27, 2020·Updated Apr 28, 2026

In Brief

A Phase 2 clinical trial evaluating EAW+SCES (exoskelton and spinal cord epidural stimulation) and EAW+TS (exoskelton and transspinal stimulation) for Spinal Cord Injury. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartJun 1, 2020
Primary CompletionJul 31, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.4 years ago

Interventions

EAW+SCES (exoskelton and spinal cord epidural stimulation)device

Three months of exoskeleton training followed by 6 months of epidural stimulation.

EAW+TS (exoskelton and transspinal stimulation)device

Three months of exoskeleton training followed by 6 months of transspinal stimulation.