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 : April 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries | Device: Epidural Stimulation Biological: Stand Training | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 8, 2017 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Voluntary Movement Epidural Stimulation
Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
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Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. |
Experimental: Cardiovascular Epidural Stimulation
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
|
Device: Epidural Stimulation
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. |
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.
|
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: Cardiovascular ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.
|
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. |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364660
Contact: Susan J Harkema, PhD | 502-581-8675 | susan.harkema@louisville.edu | |
Contact: Taylor A Blades, MS | 502-582-7410 | taylor.blades@louisville.edu |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Susan Harkema, PhD 502-581-8675 taylor.blades@louisville.edu |
Principal Investigator: | Susan J Harkema, PhD | University of Louisville |
Documents provided by Susan Harkema, University of Louisville:
Responsible Party: | Susan Harkema, Professor, University of Louisville |
ClinicalTrials.gov Identifier: | NCT03364660 |
Other Study ID Numbers: |
16.0179 TS EPI |
First Posted: | December 6, 2017 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share individual participant data. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Epidural Stimulation Spinal Cord Injury Task-Specific |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |