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Active, Not Recruiting

NCT Number: NCT04123847

Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Stand-scES, Step-scES, Vol-scES

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Susan Harkema PhD

Other

Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 11, 2019
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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