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Epi Stim to Facilitate Standing and Stepping

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ClinicalTrials.gov Identifier: NCT02339233
Recruitment Status : Recruiting
First Posted : January 15, 2015
Last Update Posted : February 28, 2018
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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Locomotor Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury
Study Start Date : January 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-S2 area of the spinal cord
Biological: Locomotor Training
Standing and Stepping in a body weight support (BWS) harness on a treadmill with/out EMG evaluation
Other Name: LT




Primary Outcome Measures :
  1. Voluntary Movement [ Time Frame: 20 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    1. stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with BWST;
    2. no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
    3. no clinically significant depression or ongoing drug abuse;
    4. no current anti-spasticity medication regimen;
    5. non-progressive SCI above T10;
    6. must not have received botox injections in the prior six months;
    7. be unable to stand or step independently;
    8. at least one-year post injury; and
    9. 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:

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

Exclusion Criteria:

  1. Ventilatory dependent
  2. painful musculoskeletal function, unhealed fracture, contracture, or pressure sore that might interfere with training;
  3. clinically significant depression or ongoing drug abuse;
  4. cardiovascular, respiratory, bladder or renal disease unrelated to SCI;
  5. severe anemia (Hgb<8 g/dL) or hypovolemia; and
  6. HIV or AIDS related illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339233


Contacts
Contact: Claudia Angeli, PhD 502-582-8675 locomotorresearch@kentuckyonehealth.org

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan J Harkema, PhD    502-581-7443    locomotorresearch@kentuckyonehealth.org   
Principal Investigator: Susan J Harkema, PhD         
Sponsors and Collaborators
University of Louisville
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)

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Harkema, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02339233     History of Changes
Other Study ID Numbers: 07.0066 Epi Stim
5R01EB007615 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Susan Harkema, University of Louisville:
Epidural Stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries