search
Back to results

Task-specific Epidural Stimulation Study (TS EPI)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural Stimulation
Stand Training
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Epidural Stimulation, Spinal Cord Injury, Task-Specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Voluntary Movement Epidural Stimulation

Cardiovascular Epidural Stimulation

Voluntary Movement ES + Stand Training

Cardiovascular ES + Stand Training

Arm Description

Participants assigned to this group will receive epidural stimulation specific for voluntary movement.

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.

Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.

Outcomes

Primary Outcome Measures

Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Recovery of voluntary movement as assessed by functional movement assessments

Secondary Outcome Measures

Full Information

First Posted
November 16, 2017
Last Updated
November 14, 2022
Sponsor
University of Louisville
Collaborators
Christopher Reeve Paralysis Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03364660
Brief Title
Task-specific Epidural Stimulation Study
Acronym
TS EPI
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Christopher Reeve Paralysis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Epidural Stimulation, Spinal Cord Injury, Task-Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voluntary Movement Epidural Stimulation
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
Arm Title
Cardiovascular Epidural Stimulation
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
Arm Title
Voluntary Movement ES + Stand Training
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
Arm Title
Cardiovascular ES + Stand Training
Arm Type
Experimental
Arm Description
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
Intervention Type
Device
Intervention Name(s)
Epidural Stimulation
Intervention Description
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
Intervention Type
Biological
Intervention Name(s)
Stand Training
Intervention Description
Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.
Primary Outcome Measure Information:
Title
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Time Frame
20 months
Title
Recovery of voluntary movement as assessed by functional movement assessments
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan J Harkema, PhD
Phone
502-581-8675
Email
susan.harkema@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor A Blades, MS
Phone
502-582-7410
Email
taylor.blades@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Harkema, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD
Phone
502-581-8675
Email
taylor.blades@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.

Learn more about this trial

Task-specific Epidural Stimulation Study

We'll reach out to this number within 24 hrs