Epi Stim to Facilitate Standing and Stepping

NCT02339233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-04-22

Study results available
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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.

Conditions

  • Spinal Cord Injury

Interventions

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.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER
  • Christopher Reeve Paralysis Foundation

    collaborator OTHER
  • Kessler Foundation

    collaborator OTHER
  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH
  • University of Louisville

    lead OTHER

Principal Investigators

  • Susan Harkema, PhD · University of Louisville

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2019-10-03
Completion
2019-10-03

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339233 on ClinicalTrials.gov