Epi Stim to Facilitate Standing and Stepping
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ClinicalTrials.gov Identifier: NCT02339233 |
Recruitment Status :
Completed
First Posted : January 15, 2015
Results First Posted : April 22, 2022
Last Update Posted : April 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injury | Device: Standing and Stepping with spinal cord Epidural Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury |
Actual Study Start Date : | January 1, 2010 |
Actual Primary Completion Date : | October 3, 2019 |
Actual Study Completion Date : | October 3, 2019 |

Arm | Intervention/treatment |
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Experimental: Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
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Device: Standing and Stepping with spinal cord Epidural Stimulation
Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
Other Names:
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- Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year) [ Time Frame: Baseline, 160 sessions (1 year) ]We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
- Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year) [ Time Frame: Baseline, 160 session (1 year) ]We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
- Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year) [ Time Frame: Baseline, 160 sessions (1 year) ]We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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All research participants, irrespective of age or sex, will meet the following criteria:
- stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with BWST;
- no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
- no clinically significant depression or ongoing drug abuse;
- no current anti-spasticity medication regimen;
- non-progressive SCI above T10;
- must not have received botox injections in the prior six months;
- be unable to stand or step independently;
- at least one-year post injury; and
- must be at least 18 years of age.
In addition, all subjects must satisfy each of the three conditions of the functional neurophysiological assessment described below.
Functional Neurophysiological Assessment (FNPA). We will use FNPA to screen potential research participants based on specific neurophysiological inclusion criteria. Participants must have no volitional control of movement below the level of the lesion, but must retain some brain influence on spinal reflexes. Our target population, which will be identified by FNPA, cannot be identified reliable using traditional assessments: hence individual subjects may be classified widely as Class A, B, or C on the ASIA SCI scale. We will include only subjects who fulfill the following three requirements:
- There is no descending volitional control of movement below the lesion
- Segmental reflexes remain functional below the lesion
- Brain influence on spinal reflexes is retained
Exclusion Criteria:
- Ventilatory dependent
- painful musculoskeletal function, unhealed fracture, contracture, or pressure sore that might interfere with training;
- clinically significant depression or ongoing drug abuse;
- cardiovascular, respiratory, bladder or renal disease unrelated to SCI;
- severe anemia (Hgb<8 g/dL) or hypovolemia; and
- HIV or AIDS related illness.

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): NCT02339233
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Susan Harkema, PhD | University of Louisville |
Documents provided by Susan Harkema, University of Louisville:
Other Publications:
Responsible Party: | Susan Harkema, Professor, University of Louisville |
ClinicalTrials.gov Identifier: | NCT02339233 |
Other Study ID Numbers: |
07.0066 Epi Stim 5R01EB007615 ( U.S. NIH Grant/Contract ) |
First Posted: | January 15, 2015 Key Record Dates |
Results First Posted: | April 22, 2022 |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Epidural Stimulation |
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |