Task-specific Epidural Stimulation Study
TSEPI
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedFirst Submitted
Initial submission to the registry
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedAugust 28, 2024
August 1, 2024
7.1 years
November 16, 2017
August 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
up to 20 months
Recovery of voluntary movement as assessed by functional movement assessments
up to 20 months
Study Arms (5)
Acute Epidural Stimulation for Cardiovascular Stability.
EXPERIMENTALParticipants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia.
Epidural Stimulation for Cardiovascular stability during daily activities
EXPERIMENTALParticipants assigned to this arm will receive be randomized to receive epidural stimulation specific for cardiovascular function alone or cardiovascular function and standing, or voluntary movement alone or voluntary movement and standing.
Voluntary Movement ES + Stand Training
EXPERIMENTALParticipants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
Cardiovascular ES + Stand Training
EXPERIMENTALParticipants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
Epidural Stimulation for Voluntary Movement
EXPERIMENTALParticipants assigned to this group receive epidural stimulation specifically for voluntary movement.
Interventions
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement, 4-7 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Louisvillelead
- Christopher Reeve Paralysis Foundationcollaborator
Study Sites (1)
University of Louisville
Louisville, Kentucky, 40202, United States
Related Publications (1)
Angeli CA, Rejc E, Ugiliweneza B, Boakye M, Forrest GF, Brockman K, Vogt J, Logsdon B, Fields K, Harkema SJ. Activity-based recovery training with spinal cord epidural stimulation improves standing performance in cervical spinal cord injury. J Neuroeng Rehabil. 2025 Apr 30;22(1):101. doi: 10.1186/s12984-025-01636-6.
PMID: 40301929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J Harkema, PhD
University of Louisville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 16, 2017
First Posted
December 6, 2017
Study Start
November 8, 2017
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
August 28, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share individual participant data.