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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 : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Susan Harkema, University of Louisville

November 16, 2017
December 6, 2017
December 6, 2017
November 8, 2017
November 30, 2022   (Final data collection date for primary outcome measure)
  • Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments [ Time Frame: 20 months ]
  • Recovery of voluntary movement as assessed by functional movement assessments [ Time Frame: 20 months ]
  • Recovery of the ability to independently stand as assessed by standing assessments [ Time Frame: 20 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Task-specific Epidural Stimulation Study
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
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.

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=6) 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).
  • Stand-ES during sitting or lying supine (A3).

Group B:

  • Stand-ES during stand training + Vol-scES during voluntary leg movement training (B1).
  • Stand-ES during stand training + CV-ES during sitting or lying supine (B2).
  • ES Stand Parameters during stand training (B3).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injuries
  • 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: Voluntary Movement Epidural Stimulation
    Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
    Intervention: Device: Epidural Stimulation
  • Experimental: Cardiovascular Epidural Stimulation
    Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
    Intervention: Device: Epidural Stimulation
  • Experimental: Stand Epidural Stimulation
    Participants assigned to this group will receive epidural stimulation specific for standing.
    Intervention: Device: Epidural Stimulation
  • 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.
    Interventions:
    • Device: Epidural Stimulation
    • Biological: Stand Training
  • Experimental: Cardiovascular ES + Stand Training
    Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
    Interventions:
    • Device: Epidural Stimulation
    • Biological: Stand Training
  • Experimental: Stand ES + Stand Training
    Participants assigned to this group will receive epidural stimulation specific for standing and will also receive stand training.
    Interventions:
    • Device: Epidural Stimulation
    • Biological: Stand Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Same as current
June 30, 2023
November 30, 2022   (Final data collection date for primary outcome measure)

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
  • Ongoing nicotine use
  • Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Susan J Harkema, PhD 502-581-8675 SusanHarkema@KentuckyOneHealth.org
Contact: Taylor A Blades, MS 502-587-7410 TaylorBlades@KentuckyOneHealth.org
United States
 
 
NCT03364660
16.0179 TS EPI
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Susan Harkema, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Susan J Harkema, PhD University of Louisville
University of Louisville
November 2017

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