Actively Recruiting
Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
Led by University of Louisville · Updated on 2026-04-28
40
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
K
Kentucky Spinal Cord and Head Injury Research Board
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if non-invasive spinal cord stimulation intervention improves blood pressure regulation in individuals with chronic spinal cord injury. The main questions it aims to answer are: * Can site specific spinal cord stimulation enhance blood pressure regulation? * Does this stimulation affect enzymes responsible for blood pressure regulation? Researchers will stimulate different sites of spinal cord and compare to see if site-specific stimulation provide blood pressure stability. Participants will have up to six pairs of self-adhesive conductive electrodes placed on the skin over the spinal cord (midline and/or just to the left and right of midline) as cathodes and up to six pairs of self-adhesive electrodes located symmetrically on the skin over the iliac crests, clavicles, shoulders, and/or abdominal muscles (left and right of the umbilicus) as anodes for stimulation of the spinal cord.
CONDITIONS
Official Title
Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Stable medical condition
- Non-progression spinal cord injury with no worsening neurological status compared to 6 months post-injury or at least 6 months before screening
- Motor-complete spinal cord injury (ASIA Impairment Scale grade A, B, or C) above T1 spinal level
- Spinal cord injury sustained at least 12 months before entering the study
- Evidence of symptomatic hypotension with a total score above 0 on the Orthostatic Hypotension Symptom Assessment
- Normal kidney function defined by eGFR > 59 ml/min/1.73, creatinine 0.6-1.2 mg/dl, and BUN 7-18 mg/dl
- Able and competent to give informed consent
- Able to understand study instructions
You will not qualify if you...
- Major pulmonary or cardiovascular disease unrelated to spinal cord injury
- Dependence on a ventilator
- Painful musculoskeletal problems interfering with testing or stimulation
- Unhealed fractures interfering with testing or stimulation
- Unhealed contractures interfering with testing or stimulation
- Unhealed pressure sores interfering with testing or stimulation
- Untreated significant depression or psychiatric disorders
- Ongoing drug abuse
- Cancer (malignancy)
- Class III obesity (BMI >40) with at least one of: type 2 diabetes (A1C ≥6.5% on two tests), hypertension (blood pressure ≥140/90 mmHg or on blood pressure medication)
- Acute or chronic deep vein thrombosis
- Secondary hypotension unrelated to spinal cord injury (due to anemia, hypervolemia, endocrine or neurological diseases)
- Major esophageal or gastrointestinal problems
- Currently pregnant (females of childbearing potential only)
- Other major medical illnesses contraindicating testing or stimulation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
2
Frazier Rehabilitation Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Andrea M Willhite
CONTACT
K
Kristin Benton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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