Spinal Cord InjuriesTSEPINCT03364660
Task-specific Epidural Stimulation Study
A study testing Acute epidural stimulation for cardiovascular stability, Long Term Epidural Stimulation for Cardiovascular Stability and Participants undergo approximately 4 months of epidural stimulation for voluntary movement. in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acute epidural stimulation for cardiovascular stability, Long Term Epidural Stimulation for Cardiovascular Stability and Participants undergo approximately 4 months of epidural stimulation for voluntary movement.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Susan Harkema, PhD, 502-582-7443, susan.harkema@louisville.edu
About this study
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
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.
Read the 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).
- Conditions
- Spinal Cord Injuries
- Being tested
- Acute epidural stimulation for cardiovascular stability, Long Term Epidural Stimulation for Cardiovascular Stability, Participants undergo approximately 4 months of epidural stimulation for voluntary movement., Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training, Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.
- Keywords
- Epidural Stimulation, Spinal Cord Injury, Task-Specific
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute epidural stimulation for cardiovascular stabilityDevice
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 StabilityDevice
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement.Device
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
Long Term Epidural Stimulation for Cardiovascular Stability plus Stand TrainingDevice
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.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Epidural Stimulation for Cardiovascular Stability. | Experimental | Participants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia. Receives: Device: Acute epidural stimulation for cardiovascular stability |
| Epidural Stimulation for Cardiovascular stability during daily activities | Experimental | 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. Receives: Device: Long Term Epidural Stimulation for Cardiovascular Stability |
| Voluntary Movement ES + Stand Training | Experimental | Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training. Receives: Device: Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training. |
| Cardiovascular ES + Stand Training | Experimental | Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training. Receives: Device: Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training |
| Epidural Stimulation for Voluntary Movement | Experimental | Participants assigned to this group receive epidural stimulation specifically for voluntary movement. Receives: Device: Participants undergo approximately 4 months of epidural stimulation for voluntary movement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Measured: up to 20 months
Recovery of voluntary movement as assessed by functional movement assessments
Measured: up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start8 Nov 2017
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation
- Responsible party
- Principal investigator, Susan Harkema PhD, University of Louisville
- Investigators
- Susan J Harkema, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364660
- Sponsor's protocol ID
- 16.0179 TS EPI
- Acronym
- TSEPI
- Status last verified
- Aug 2024
- First submitted
- 16 Nov 2017
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data.
Publications
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.
PubMed 40301929
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03364660
- Acronym / sponsor ID
- TSEPI / 16.0179 TS EPI
- Conditions
- Spinal Cord Injuries
- Keywords
- Epidural Stimulation, Spinal Cord Injury, Task-Specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acute Epidural Stimulation for Cardiovascular Stability. | Experimental | Device: Acute epidural stimulation for cardiovascular stabilityParticipants 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 | Experimental | Device: Long Term Epidural Stimulation for Cardiovascular StabilityParticipants 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 | Experimental | Device: Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training.Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training. |
| Cardiovascular ES + Stand Training | Experimental | Device: Long Term Epidural Stimulation for Cardiovascular Stability plus Stand TrainingParticipants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training. |
| Epidural Stimulation for Voluntary Movement | Experimental | Device: Participants undergo approximately 4 months of epidural stimulation for voluntary movement.Participants assigned to this group receive epidural stimulation specifically for voluntary movement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute epidural stimulation for cardiovascular stabilityEligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability. | Device | Acute Epidural Stimulation for Cardiovascular Stability. |
| Long Term Epidural Stimulation for Cardiovascular StabilityParticipants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily. | Device | Epidural Stimulation for Cardiovascular stability during daily activities |
| 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. | Device | Epidural Stimulation for Voluntary Movement |
| Long Term Epidural Stimulation for Cardiovascular Stability plus Stand TrainingParticipants 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. | Device | Cardiovascular ES + 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. | Device | Voluntary Movement ES + Stand Training |
Primary outcome
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Time frame: up to 20 months
Recovery of voluntary movement as assessed by functional movement assessments
Time frame: up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 40301929Angeli 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Harkema, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute epidural stimulation for cardiovascular stability, Long Term Epidural Stimulation for Cardiovascular Stability and Participants undergo approximately 4 months of epidural stimulation for voluntary movement. in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan J Harkema, PhD (502-582-7443, susan.harkema@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments (time frame: up to 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.