Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

NCT04123847 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17.1024 MC-PP-2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

epidural stimulation

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline, 160 sessions (1 year)

• Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)

  We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout

  Baseline, 160 sessions (1 year)

• Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)

  We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1-minute period

  Baseline, 160 sessions (1 year)

Secondary Outcomes (15)

• Change from baseline in resting metabolic rate after 160 sessions (1 year)

  Baseline, 160 sessions (1 year)

• Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)

  Baseline, 160 sessions (1 year)

• Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)

  Baseline, 160 sessions (1 year)

• Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)

  Baseline, 160 sessions (1 year)

• Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)

  Baseline, 160 sessions (1 year)

Study Arms (1)

Stand, Step and Voluntary Training

EXPERIMENTAL

Other: Standing and Stepping; Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

Interventions

Standing and Stepping 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.

Stand, Step and Voluntary Training

Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation 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.

Also known as: Stand-scES, Step-scES, Vol-scES

Stand, Step and Voluntary Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susan Harkema PhD: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Standing Position

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susan Harkema, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: October 11, 2019
• Study Start: November 2, 2020
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)