- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123847
Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation
December 14, 2023 updated by: Susan Harkema PhD
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
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stand, Step and Voluntary Training
|
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.
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:
|
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)
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
|
Baseline, 160 sessions (1 year)
|
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
|
Baseline, 160 sessions (1 year)
|
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
|
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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 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)
Time Frame: Baseline, 160 sessions (1 year)
|
We will measure change in sexual health function using a questionnaire.
|
Baseline, 160 sessions (1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Harkema, PhD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Epidural Spinal Cord CompressionUnited States
Clinical Trials on Standing and Stepping
-
Mayo ClinicCompleted
-
University of BedfordshireRecruitingCardiovascular DiseasesUnited Kingdom
-
University of LouisvilleUniversity of California, Los Angeles; National Institute for Biomedical Imaging... and other collaboratorsCompleted
-
Medical Research Council, South AfricaNational Institute of Mental Health (NIMH)CompletedStepping Stones Program for Preventing HIV Infection in Residents of Rural South African CommunitiesHIV InfectionsSouth Africa
-
National Yang Ming UniversityUnknown
-
San Diego State UniversityRecruiting
-
Khon Kaen UniversityCompletedSpinal Cord InjuriesThailand
-
New York Institute of TechnologyRecruitingPhysical Therapy | Rehabilitation ExerciseUnited States
-
Khon Kaen UniversityCompletedSpinal Cord InjuriesThailand
-
Toronto Rehabilitation InstituteOntario Neurotrauma FoundationCompletedSpinal Cord Injury. | Osteoporosis.Canada