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Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

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ClinicalTrials.gov Identifier: NCT04123847
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Standing and Stepping Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year) [ Time Frame: Baseline, 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

  2. Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year) [ Time Frame: Baseline, 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

  3. Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year) [ Time Frame: Baseline, 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


Secondary Outcome Measures :
  1. Change from baseline in resting metabolic rate after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Resting metabolic rate

  2. Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Respiratory Motor Control Assessment

  3. Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Respiratory Motor Control Assessment

  4. Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Respiratory Motor Control Assessment

  5. Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Respiratory Motor Control Assessment (RMCA)

  6. Change from baseline in bladder capacity after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using urodynamics we will measure bladder capacity in mL.

  7. Change from baseline in bladder voiding efficiency after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.

  8. Change from baseline in detrusor pressures during filling after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using urodynamics we will measure detrusor pressure in cmH2O.

  9. Change from baseline in bladder compliance after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using urodynamics we will measure bladder compliance in mL/cmH2O.

  10. Change from baseline in mean resting anal pressure after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using anorectal manometry we will measure mean resting pressure in mmHg.

  11. Change from baseline in mean squeeze pressure after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using anorectal manometry we will measure mean squeeze pressure in mmHg.

  12. Change from baseline in mean squeeze increase pressure after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using anorectal manometry we will measure mean squeeze increase pressure in mmHg.

  13. Change from baseline in squeeze anal canal length after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using anorectal manometry will measure squeeze anal canal length in cm.

  14. Change from baseline in bowel sensation after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    Using anorectal manometry we will measure bowel sensation in mL.

  15. Change in baseline in sexual function after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]
    We will measure change in sexual health function using a questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123847


Contacts
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Contact: Claudia Angeli, PhD 502-581-8675 victory1@louisville.edu
Contact: Susan Harkema, PhD 502-581-8675 victory1@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Claudia Angeli, PhD    502-581-8675    victory1@louisville.edu   
Sub-Investigator: Claudia Angeli, PhD         
Principal Investigator: Susan Harkema, PhD         
Sponsors and Collaborators
Susan Harkema
The Leona M. and Harry B. Helmsley Charitable Trust
Investigators
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Principal Investigator: Susan Harkema, PhD University of Louisville
More Information
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Responsible Party: Susan Harkema, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04123847    
Other Study ID Numbers: 17.1024 MC-PP-2
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Susan Harkema, University of Louisville:
epidural stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System