Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury

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 Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Standing and Stepping; Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stand, Step and Voluntary Training

Other: 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.; Device: 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.; Other Names: Stand-scES; Step-scES; Vol-scES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in resting metabolic rate after 160 sessions (1 year)	Resting metabolic rate	Baseline, 160 sessions (1 year)
Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)	Respiratory Motor Control Assessment	Baseline, 160 sessions (1 year)
Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)	Respiratory Motor Control Assessment (RMCA)	Baseline, 160 sessions (1 year)
Change from baseline in bladder capacity after 160 sessions (1 year)	Using urodynamics we will measure bladder capacity in mL.	Baseline, 160 sessions (1 year)
Change from baseline in bladder voiding efficiency after 160 sessions (1 year)	Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.	Baseline, 160 sessions (1 year)
Change from baseline in detrusor pressures during filling after 160 sessions (1 year)	Using urodynamics we will measure detrusor pressure in cmH2O.	Baseline, 160 sessions (1 year)
Change from baseline in bladder compliance after 160 sessions (1 year)	Using urodynamics we will measure bladder compliance in mL/cmH2O.	Baseline, 160 sessions (1 year)
Change from baseline in mean resting anal pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean resting pressure in mmHg.	Baseline, 160 sessions (1 year)
Change from baseline in mean squeeze pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean squeeze pressure in mmHg.	Baseline, 160 sessions (1 year)
Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)	Using anorectal manometry we will measure mean squeeze increase pressure in mmHg.	Baseline, 160 sessions (1 year)
Change from baseline in squeeze anal canal length after 160 sessions (1 year)	Using anorectal manometry will measure squeeze anal canal length in cm.	Baseline, 160 sessions (1 year)
Change from baseline in bowel sensation after 160 sessions (1 year)	Using anorectal manometry we will measure bowel sensation in mL.	Baseline, 160 sessions (1 year)
Change in baseline in sexual function after 160 sessions (1 year)	We will measure change in sexual health function using a questionnaire.	Baseline, 160 sessions (1 year)

Collaborators and Investigators

• Sponsor: Susan Harkema PhD
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Principal Investigator: Susan Harkema, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: epidural stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 17.1024 MC-PP-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes