Epi Stim to Facilitate Standing and Stepping
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02339233 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standing and Stepping with spinal cord Epidural Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year) |
40.6 | — |
| PRIMARY Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year) |
197.13 | — |
| SECONDARY Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year) |
14.25 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02339233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.