Epi Stim to Facilitate Standing and Stepping

April 21, 2022 updated by: Susan Harkema, University of Louisville

Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

8

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

  • United States
    • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
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)

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 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
Baseline, 160 session (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

University of California, Los Angeles
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Kessler Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
Christopher Reeve Paralysis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2010

Primary Completion (Actual)

October 3, 2019

Study Completion (Actual)

October 3, 2019

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.0066 Epi Stim
  • 5R01EB007615 (U.S. NIH Grant/Contract)

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.

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