N/A
N=5
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02037620 ↗Enrolled (actual)
5
Serious AEs
60.0%
Results posted
Mar 2022
Primary outcome: Primary: Mean Arterial Blood Pressure in Response to Epidural Stimulation — 112.5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5-6-5 Specify electrode (Device); Restore Advance Pulse Generator (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Arterial Blood Pressure in Response to Epidural Stimulation |
112.5 | — |
Summary
We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.
Eligibility Criteria
- non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C;
- 21 - 70 years of age;
- greater than 2 years post injury;
- stable medical condition;
- unable to voluntarily move all single joints of the legs;
- cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and
- respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes;
Exclusion Criteria
- ventilator dependent;
- painful musculoskeletal dysfunction, 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 hypovelemia; and
- HIV or AIDS related illness.
Data sourced from ClinicalTrials.gov (NCT02037620). 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.