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Active, not recruitingNCT04123847Updated Dec 17, 2024

Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

An interventional study of Standing and Stepping and Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation in Spinal Cord Injuries, sponsored by Susan Harkema PhD. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by Susan Harkema PhD · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Cord Injuries

Keywords

  • epidural stimulation
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's enrollment of 16 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

This is the only study on the registry with Susan Harkema PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Stand, Step and Voluntary Training

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

Interventions

  • OtherStanding 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.

  • DeviceStanding, 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.

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 160 sessions (1 year)

  2. 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

    Time frame: Baseline, 160 sessions (1 year)

  3. 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

    Time frame: Baseline, 160 sessions (1 year)

Secondary outcomes

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

    Resting metabolic rate

    Time frame: Baseline, 160 sessions (1 year)

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

    Respiratory Motor Control Assessment

    Time frame: Baseline, 160 sessions (1 year)

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

    Respiratory Motor Control Assessment

    Time frame: Baseline, 160 sessions (1 year)

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

    Respiratory Motor Control Assessment

    Time frame: Baseline, 160 sessions (1 year)

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

    Respiratory Motor Control Assessment (RMCA)

    Time frame: Baseline, 160 sessions (1 year)

  6. Change from baseline in bladder capacity after 160 sessions (1 year)

    Using urodynamics we will measure bladder capacity in mL.

    Time frame: Baseline, 160 sessions (1 year)

  7. Change from baseline in bladder voiding efficiency after 160 sessions (1 year)

    Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.

    Time frame: Baseline, 160 sessions (1 year)

  8. Change from baseline in detrusor pressures during filling after 160 sessions (1 year)

    Using urodynamics we will measure detrusor pressure in cmH2O.

    Time frame: Baseline, 160 sessions (1 year)

  9. Change from baseline in bladder compliance after 160 sessions (1 year)

    Using urodynamics we will measure bladder compliance in mL/cmH2O.

    Time frame: Baseline, 160 sessions (1 year)

  10. Change from baseline in mean resting anal pressure after 160 sessions (1 year)

    Using anorectal manometry we will measure mean resting pressure in mmHg.

    Time frame: Baseline, 160 sessions (1 year)

  11. Change from baseline in mean squeeze pressure after 160 sessions (1 year)

    Using anorectal manometry we will measure mean squeeze pressure in mmHg.

    Time frame: Baseline, 160 sessions (1 year)

  12. 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.

    Time frame: Baseline, 160 sessions (1 year)

  13. Change from baseline in squeeze anal canal length after 160 sessions (1 year)

    Using anorectal manometry will measure squeeze anal canal length in cm.

    Time frame: Baseline, 160 sessions (1 year)

  14. Change from baseline in bowel sensation after 160 sessions (1 year)

    Using anorectal manometry we will measure bowel sensation in mL.

    Time frame: Baseline, 160 sessions (1 year)

  15. Change in baseline in sexual function after 160 sessions (1 year)

    We will measure change in sexual health function using a questionnaire.

    Time frame: Baseline, 160 sessions (1 year)

07

Study locations

1 site
  • University of Louisville
    Louisville, Kentucky 40202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04123847
Lead sponsor
Susan Harkema PhD
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust
Responsible party
Susan Harkema PhD (Professor, University of Louisville) — Sponsor-investigator
First posted
Oct 11, 2019
Start date
Nov 2, 2020
Primary completion
Nov 26, 2025 (estimated)
Completion
Nov 26, 2025 (estimated)
Last update
Dec 17, 2024

Study contacts

Susan Harkema, PhD
principal investigator · University of Louisville

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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