Non-invasive spinal cord stimulation to improve blood pressure control after spinal cord injury
Official title: Effectiveness of Transcutaneous Spinal Cord Stimulation on Blood Pressure Regulation in Individuals With Chronic Spinal Cord Injury
Run by University of Louisville · NCT07504055 · Data updated 2026-11-12
We will test whether non-invasive spinal cord stimulation can help adults with chronic spinal cord injuries at or above T1 who have troublesome low or unstable blood pressure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Louisville Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | February 2029 |
| Study ends | February 2029 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07504055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with chronic (≥12 months), non-progressive motor-complete SCI (AIS A, B, or C) at or above T1 who have symptomatic orthostatic hypotension, stable medical status, normal renal function, and capacity to consent.
✕Probably not a fit
People with progressive neurological disease, recent spinal cord injury (<12 months), injuries below T1, significant medical instability or renal dysfunction, or who cannot tolerate or attend frequent stimulation sessions are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol delivers transcutaneous spinal cord stimulation using pairs of self-adhesive electrodes placed along the midline and lateral spinal locations with return electrodes on the iliac crests, clavicles, shoulders, or abdomen. Participants complete up to 80 one-hour stimulation sessions over 16–20 weeks (4–5 days per week) with frequencies up to 100 Hz and intensities titrated up to 200 mA, including mapping and site-specific comparisons. Physiological and biochemical measures are collected at baseline, several intervention milestones, post-intervention, and two follow-ups to track blood pressure stability and enzyme changes related to blood pressure control. The study plans to recruit up to 40 people with a goal of 15 completers to inform whether targeted site-specific stimulation strengthens neurohormonal pathways and reduces hypotensive and hypertensive episodes.
Why it matters
Potential benefit: If successful, the intervention could improve cardiovascular stability, reduce the frequency and severity of hypotensive and hypertensive episodes, and enhance quality of life for people with high-level chronic spinal cord injury.
How similar studies have gone: Early case reports and small studies of transcutaneous and epidural spinal stimulation have shown promising improvements in autonomic cardiovascular function, but controlled evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old, * Stable medical condition, * Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological status assessed at 6-month period after injury or at least 6 months prior to the screening), * Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade "A," "B," or "C" above T1 spinal level according to the ASIA International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury (NLI), * Sustained SCI at least 12 months prior to entering the study, * Evidence of symptomatic hypotension as determined by a total score \>0 on the Orthostatic Hypotension Symptom Assessment (OSHA), * Normal renal function as defined by eGFR \> 59 ml/min/1.73, creatinine value within the range of 0.6-1.2 mg/dl, and BUN values within the range of 7-18 mg/dl, * Competent to give informed consent for the research protocol, * Able to understand instructions. Exclusion Criteria: * Major pulmonary or cardiovascular disease unrelated to SCI, * Ventilator dependence, * Painful musculoskeletal dysfunction that might interfere with testing or stimulation, * Unhealed fracture that might interfere with testing or stimulation, * Unhealed contracture that might interfere with testing or stimulation, * Unhealed pressure sore that might interfere with testing or stimulation, * Untreated clinically significant depression or psychiatric disorders, * Ongoing drug abuse, * Malignancy , * Class III obesity (BMI \>40) and at least one co-morbidity thereof: a) Type 2 diabetes as defined by ≥6.5% level on two separate glycated hemoglobin (A1C) tests, b) hypertension as defined by consistent blood pressure readings of ≥140/90 mmHg or taking medication for blood pressure, * Acute or chronic obstructive deep vein thrombosis, * Secondary hypotension unrelated to SCI (anemia, hypervolemia, endocrine and neurological diseases), * Major esophageal/gastrointestinal problem, * Currently pregnant (females of childbearing potential only), * Other major medical illness contraindicated for testing or stimulation.
Where it's running
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Frazier Rehabilitation Institute
Louisville, Kentucky, United States Recruiting -
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States Not yet recruiting
Study contacts
- Principal investigator: Alexander Ovechkin — University of Louisville
- Study coordinator: Andrea M Willhite
- Email: andrea.willhite@louisville.edu
- Phone: 1-502-581-8675
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.