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 : October 11, 2019
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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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
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 |
Estimated Study Start Date : | November 2019 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | November 2024 |

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:
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- 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
- 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
- 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
- Change from baseline in resting metabolic rate after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]Resting metabolic rate
- Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]Respiratory Motor Control Assessment
- Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year) [ Time Frame: Baseline, 160 sessions (1 year) ]Respiratory Motor Control Assessment
- 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
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

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
Contact: Claudia Angeli, PhD | 502-581-8675 | LocomotorResearch@KentuckyOneHealth.org | |
Contact: Susan Harkema, PhD | 502-581-8675 | LocomotorResearch@KentuckyOneHealth.org |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Claudia Angeli, PhD 502-581-8675 LocomotorResearch@KentuckyOneHealth.org | |
Sub-Investigator: Claudia Angeli, PhD | |
Principal Investigator: Susan Harkema, PhD |
Principal Investigator: | Susan Harkema, PhD | University of Louisville |
Responsible Party: | Susan Harkema, Professor, University of Louisville |
ClinicalTrials.gov Identifier: | NCT04123847 History of Changes |
Other Study ID Numbers: |
17.1024 MC-PP-2 |
First Posted: | October 11, 2019 Key Record Dates |
Last Update Posted: | October 11, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | No |
epidural stimulation |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |