Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epi Stim to Facilitate Standing and Stepping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339233
Recruitment Status : Active, not recruiting
First Posted : January 15, 2015
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
Christopher Reeve Paralysis Foundation
Kessler Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE January 15, 2015
Last Update Posted Date March 27, 2020
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 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 session (1 year) ]
    We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
Voluntary Movement [ Time Frame: 20 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
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 Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epi Stim to Facilitate Standing and Stepping
Official Title  ICMJE Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury
Brief Summary The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. The investigators propose that locomotor training will result in generation of more effective standing and stepping efferent patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The investigators propose that the SCES will optimize the physiological state of the spinal cord interneuronal circuitry compromised by compensating for loss of supraspinal input for the retraining of these tasks.
Detailed Description Participants will be screened for eligibility and then participate in pre-training motor, bladder and cardiovascular experiments, followed by 80 sessions of locomotor training. Participants will repeat experiments after the 80 training sessions to quantify that no motor pattern changes are achievable with locomotor training alone and will be evaluated for appropriate candidacy for surgery and epidural stimulation. Participants will be surgically implanted with an epidural stimulator and experiments will be conducted with and without stimulation. Investigators will identify appropriate stimulation parameters for inducing stepping and standing in combination with manual assistance using body weight support on a treadmill and/or overground. Participants will undergo 80-200 training sessions of locomotor training with epidural stimulation. Experiments will be repeated mid and post-training interventions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Device: Standing and Stepping with spinal cord Epidural Stimulation
Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
Other Names:
  • Stand-scES
  • Step-scES
  • Locomotor Training (LT)
Study Arms  ICMJE Experimental: Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Intervention: Device: Standing and Stepping with spinal cord Epidural Stimulation
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2015)
10
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All research participants, irrespective of age or sex, will meet the following criteria:

    • stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with BWST;
    • no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
    • no clinically significant depression or ongoing drug abuse;
    • no current anti-spasticity medication regimen;
    • non-progressive SCI above T10;
    • must not have received botox injections in the prior six months;
    • be unable to stand or step independently;
    • at least one-year post injury; and
    • must be at least 18 years of age.

In addition, all subjects must satisfy each of the three conditions of the functional neurophysiological assessment described below.

Functional Neurophysiological Assessment (FNPA). We will use FNPA to screen potential research participants based on specific neurophysiological inclusion criteria. Participants must have no volitional control of movement below the level of the lesion, but must retain some brain influence on spinal reflexes. Our target population, which will be identified by FNPA, cannot be identified reliable using traditional assessments: hence individual subjects may be classified widely as Class A, B, or C on the ASIA SCI scale. We will include only subjects who fulfill the following three requirements:

  • There is no descending volitional control of movement below the lesion
  • Segmental reflexes remain functional below the lesion
  • Brain influence on spinal reflexes is retained

Exclusion Criteria:

  • Ventilatory dependent
  • painful musculoskeletal function, unhealed fracture, contracture, or pressure sore that might interfere with training;
  • clinically significant depression or ongoing drug abuse;
  • cardiovascular, respiratory, bladder or renal disease unrelated to SCI;
  • severe anemia (Hgb<8 g/dL) or hypovolemia; and
  • HIV or AIDS related illness.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02339233
Other Study ID Numbers  ICMJE 07.0066 Epi Stim
5R01EB007615 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Harkema, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE
  • University of California, Los Angeles
  • Christopher Reeve Paralysis Foundation
  • Kessler Foundation
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators  ICMJE
Principal Investigator: Susan Harkema, PhD University of Louisville
PRS Account University of Louisville
Verification Date March 2020

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