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Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury

ClinicalTrials.gov IDNCT07504055

PhaseNA

Enrollment40

SponsorUniversity of Louisville

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Spinal Cord Injury, Orthostatic Hypertension, Autonomic Dysreflexia

About this study

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.

Interventions

Device: Spinal Cord Transcutaneous Stimulation — Spinal Cord Transcutaneous Stimulation (scTS) will be administered using the Biostim/Neostim (Cosyma Inc., Denver CO) device. Up to six pairs of self-adhesive conductive electrodes will be 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. During scTS mapping sessions, stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training (e.g., blood pressure modulation, respiratory function) targeted for each arm. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered at a level specific to each arm with frequency of up to 100 Hz, with incrementally increased intensity up to 200 mA.

Primary outcomes

Baroreflex Sensitivity (Within 4 weeks before an intervention; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after weeks after 8 weeks and 16-weeks follow-up period.)
Renal Artery Systolic Velocity (Right and Left) (Within 4 weeks before an intervention; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after weeks after 8 weeks and 16-weeks follow-up period.)
Plasma Renin Activity (Within 4 weeks before an intervention; within 2 weeks after intervention #20; within 2 weeks after intervention #40; within 2 weeks after intervention #60; within 2 weeks after intervention #80; within 2 weeks after weeks after 8 and 16-weeks follow-up.)
Angiotensin Converting Enzyme (Within 4 weeks before an intervention; within 2 weeks after intervention #20; within 2 weeks after intervention #40; within 2 weeks after intervention #60; within 2 weeks after intervention #80; within 2 weeks after weeks after 8 and 16-weeks follow-up.)
Aldosterone (Within 4 weeks before an intervention; within 2 weeks after intervention #20; within 2 weeks after intervention #40; within 2 weeks after intervention #60; within 2 weeks after intervention #80; within 2 weeks after weeks after 8 and 16-weeks follow-up.)

Eligibility information

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.

Study locations

Frazier Rehabilitation and Neuroscience Institute, Louisville, Kentucky 40202 United States
Frazier Rehabilitation Institute, Louisville, Kentucky 40202 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.