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Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

Primary Purpose

Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standing and Stepping
Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation
Sponsored by
Susan Harkema
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring epidural stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stand, Step and Voluntary Training

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Change from baseline in resting metabolic rate after 160 sessions (1 year)
Resting metabolic rate
Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)
Respiratory Motor Control Assessment
Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)
Respiratory Motor Control Assessment
Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)
Respiratory Motor Control Assessment
Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)
Respiratory Motor Control Assessment (RMCA)
Change from baseline in bladder capacity after 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)
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)
Using urodynamics we will measure detrusor pressure in cmH2O.
Change from baseline in bladder compliance after 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)
Using anorectal manometry we will measure mean resting pressure in mmHg.
Change from baseline in mean squeeze pressure after 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)
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)
Using anorectal manometry will measure squeeze anal canal length in cm.
Change from baseline in bowel sensation after 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)
We will measure change in sexual health function using a questionnaire.

Full Information

First Posted
May 30, 2019
Last Updated
November 14, 2022
Sponsor
Susan Harkema
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04123847
Brief Title
Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation
Official Title
Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Harkema
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
epidural stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stand, Step and Voluntary Training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standing and Stepping
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation
Other Intervention Name(s)
Stand-scES, Step-scES, Vol-scES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)
Description
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)
Title
Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)
Description
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)
Title
Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
Description
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 Outcome Measure Information:
Title
Change from baseline in resting metabolic rate after 160 sessions (1 year)
Description
Resting metabolic rate
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)
Description
Respiratory Motor Control Assessment
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)
Description
Respiratory Motor Control Assessment
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)
Description
Respiratory Motor Control Assessment
Time Frame
Baseline, 160 sessions (1 year)
Title
Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)
Description
Respiratory Motor Control Assessment (RMCA)
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in bladder capacity after 160 sessions (1 year)
Description
Using urodynamics we will measure bladder capacity in mL.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in bladder voiding efficiency after 160 sessions (1 year)
Description
Using urodynamics we will measure voiding efficiency (leak amount/total capacity)x100.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in detrusor pressures during filling after 160 sessions (1 year)
Description
Using urodynamics we will measure detrusor pressure in cmH2O.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in bladder compliance after 160 sessions (1 year)
Description
Using urodynamics we will measure bladder compliance in mL/cmH2O.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in mean resting anal pressure after 160 sessions (1 year)
Description
Using anorectal manometry we will measure mean resting pressure in mmHg.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in mean squeeze pressure after 160 sessions (1 year)
Description
Using anorectal manometry we will measure mean squeeze pressure in mmHg.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)
Description
Using anorectal manometry we will measure mean squeeze increase pressure in mmHg.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in squeeze anal canal length after 160 sessions (1 year)
Description
Using anorectal manometry will measure squeeze anal canal length in cm.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change from baseline in bowel sensation after 160 sessions (1 year)
Description
Using anorectal manometry we will measure bowel sensation in mL.
Time Frame
Baseline, 160 sessions (1 year)
Title
Change in baseline in sexual function after 160 sessions (1 year)
Description
We will measure change in sexual health function using a questionnaire.
Time Frame
Baseline, 160 sessions (1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation

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