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Task-specific Epidural Stimulation Study (TS EPI)

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ClinicalTrials.gov Identifier: NCT03364660
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

Study Description
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Brief Summary:
The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Epidural Stimulation Biological: Stand Training Not Applicable

Detailed Description:

Experimental Design

The investigators will enroll, implant and complete the interventions in 36 research participants who have sustained a SCI in the proposed experiments. The investigators anticipate they will need to screen 108 potential research participants to enroll 36 individuals who will complete the study. This sample size will provide sufficient replication per study group (n=4) from which variance and effect size estimates for each study hypothesis can be calculated, and hypothesis tests conducted. The investigators will also select individuals to assure that there are a minimum of 25% (n=9) women to adequately represent the percentage in the SCI population. The investigators will study each cohort of patients comprehensively, and each individual will be allocated to the group interventions based on the method of minimization. Research participants will be randomized into group interventions. This novel approach of conducting repeated experiments with comprehensive assessments in a smaller cohort of patients, rather than a more traditional approach of including a large number of patients and focusing on a single outcome, will advance both clinical and scientific knowledge in this highly complex population. The investigators have found success with the smaller cohort approach because they can employ more rigorous, quantitative and sensitive outcomes that not only inform them about the potential clinical efficacy, but also provide further knowledge of the mechanisms of neural control of movement and other physiological mechanisms related to cardiovascular, respiratory, bladder, bowel and sexual function.

Group A:

  • Vol-scES during voluntary leg movement training while sitting or lying supine (A1).
  • CV-scES during sitting or lying supine (A2).

Group B:

  • Vol-scES during voluntary leg movement training + Stand-ES during stand training (B1).
  • CV-ES during sitting or lying supine + Stand-ES during stand training (B2).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Voluntary Movement Epidural Stimulation
Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
 Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
Experimental: Cardiovascular Epidural Stimulation
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
 Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
Experimental: Voluntary Movement ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
 Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.

Biological: Stand Training
Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.
Experimental: Cardiovascular ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
 Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.

Biological: Stand Training
Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments [ Time Frame: 20 months ]
  2. Recovery of voluntary movement as assessed by functional movement assessments [ Time Frame: 20 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least 18 years of age
  • Non-progressive spinal cord injury
  • At least 2 years post injury
  • Stable medical condition
  • Unable to voluntarily move all individual joints of the legs
  • Unable to stand independently
  • Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period
  • Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
  • Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

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 spinal cord injury
  • Bladder botox injections less than 12 months prior to implant
  • Colostomy bag, urostomy
  • Any implanted pump (i.e., baclofen pump, pain pump, etc)
  • Ongoing nicotine use
  • Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Contacts and Locations
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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): NCT03364660


Contacts
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Contact: Susan J Harkema, PhD 502-581-8675 TaylorBlades@KentuckyOneHealth.org
Contact: Taylor A Blades, MS 502-582-7410 TaylorBlades@KentuckyOneHealth.org

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Harkema, PhD    502-581-8675    TaylorBlades@KentuckyOneHealth.org   
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Susan J Harkema, PhD University of Louisville
  Study Documents (Full-Text)

Documents provided by Susan Harkema, University of Louisville:
Study Protocol  [PDF] February 8, 2019

More Information
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Responsible Party: Susan Harkema, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03364660    
Other Study ID Numbers: 16.0179 TS EPI
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Susan Harkema, University of Louisville:
Epidural Stimulation
Spinal Cord Injury
Task-Specific
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System