Epi Stim to Facilitate Standing and Stepping
Spinal Cord Injury
About this trial
This is an interventional basic science trial for Spinal Cord Injury focused on measuring Epidural Stimulation
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.
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Experimental
Epidural Stimulator
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord