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Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

NCT ID: NCT04123847

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2025-11-26

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Keywords

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epidural stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Stand, Step and Voluntary Training

Group Type EXPERIMENTAL

Standing and Stepping

Intervention Type OTHER

Participants will have at least 80 sessions of stand and step training with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill.

Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

Intervention Type DEVICE

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.

Interventions

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Standing and Stepping

Participants will have at least 80 sessions of stand and step training with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill.

Intervention Type OTHER

Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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Stand-scES Step-scES Vol-scES

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Susan Harkema PhD

OTHER

Sponsor Role lead

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role collaborator

Responsible Party

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Susan Harkema PhD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Susan Harkema, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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17.1024 MC-PP-2

Identifier Type: -

Identifier Source: org_study_id