Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

N/AActive Not RecruitingNCT04123847

Susan Harkema PhD16 enrolled

Overview

This study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with scES in humans with severe paralysis. Training will consist of practicing stepping, standing and voluntary movements in the presence of specific scES configurations designed specific for stepping (Step-scES), specific for standing (Stand-scES) and for the voluntary movements of the legs and trunk (Vol-scES). Ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Standing, Stepping and Voluntary Movement with spinal cord Epidural StimulationDEVICE

Participants will be have at least 80 sessions of stand and step training with epidural stimulation, with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill. Voluntary movement with epidural stimulation will be completed in the supine or seated position.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * non-progressive SCI * at least 2 years post injury * stable medical condition * inability to walk independently overground * unable to voluntarily move all individual joints of the legs Exclusion Criteria: * ventilator dependent * untreated painful musculoskeletal dysfunction, fracture or pressure sore * untreated psychiatric disorder or ongoing drug abuse * cardiovascular, respiratory, bladder, or renal disease unrelated to SCI * pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Outcomes

Primary Outcomes

Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)

We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout