Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2017-11-08
2024-12-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acute Epidural Stimulation for Cardiovascular Stability.
Participants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia.
Acute epidural stimulation for cardiovascular stability
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
Epidural Stimulation for Cardiovascular stability during daily activities
Participants 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.
Long Term Epidural Stimulation for Cardiovascular Stability
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
Voluntary Movement ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.
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.
Cardiovascular ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training
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.
Epidural Stimulation for Voluntary Movement
Participants assigned to this group receive epidural stimulation specifically for voluntary movement.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
Interventions
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Acute epidural stimulation for cardiovascular stability
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
Long Term Epidural Stimulation 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.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training
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 plus stand training.
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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Christopher Reeve Paralysis Foundation
OTHER
University of Louisville
OTHER
Responsible Party
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Susan Harkema PhD
Professor
Principal Investigators
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Susan J Harkema, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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16.0179 TS EPI
Identifier Type: -
Identifier Source: org_study_id
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