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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
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date October 11, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation
Official Title  ICMJE Task-specific Epidural Stimulation and Training for Recovery of Stepping, Standing and Voluntary Movement Following Severe Spinal Cord Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • 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:
    • Stand-scES
    • Step-scES
    • Vol-scES
Study Arms  ICMJE Experimental: Stand, Step and Voluntary Training
Interventions:
  • Other: Standing and Stepping
  • Device: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claudia Angeli, PhD 502-581-8675 LocomotorResearch@KentuckyOneHealth.org
Contact: Susan Harkema, PhD 502-581-8675 LocomotorResearch@KentuckyOneHealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123847
Other Study ID Numbers  ICMJE 17.1024 MC-PP-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Susan Harkema, University of Louisville
Study Sponsor  ICMJE Susan Harkema
Collaborators  ICMJE The Leona M. and Harry B. Helmsley Charitable Trust
Investigators  ICMJE
Principal Investigator: Susan Harkema, PhD University of Louisville
PRS Account University of Louisville
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP