An interventional study of Spinal Cord Transcutaneous Stimulation in Spinal Cord Injury, Orthostatic Hypertension and Autonomic Dysreflexia, sponsored by University of Louisville. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Louisville · Not applicable, Interventional, and Treatment
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:
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.
This study introduces a novel mechanistic framework for treating and understanding autonomic regulation of blood pressure in SCI. The central hypothesis is that targeted specific scTS will restore cardiovascular homeostasis by strengthening complex neurohormonal pathways of blood pressure control. We expect that changes in these physiological and biochemical parameters will translate into greater cardiovascular stability, reduced frequency and severity of hypotensive and hypertensive episodes, and enhanced quality of life for individuals with SCI in individuals with Spinal Cord Injury (SCI) at the neurological level T1 and above, and more than one year after injury. The study team will recruit up to forty participants with the goal of fifteen participants to complete study interventions and assessments through the second follow-up visit. After recruitment and screening, primary and secondary outcome measures will be obtained at the following time points: 1) Pre-intervention (inclusive of randomization and mapping), 2) Session 20, 3) Mid-Intervention, 4) Session 60, 5) post-intervention, 6) 1st Follow-Up (8 weeks after post-intervention), and 7) 2nd Follow-Up (16 weeks after post-intervention). Participants will be asked to complete eighty sessions over a 16 to 20-week period, delivered 4 to 5 days per week for one hour each day. The stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200 mA to the participant for 80 sessions 1 hour long spanning 16 to 20 weeks.
Exclusion Criteria:
The participants in this arm will receive spinal cord stimulation at the thoracolumbar level (T10 to L1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
Device: Spinal Cord Transcutaneous Stimulation
The participants in this arm will receive spinal cord stimulation at the lumbosacral level (L1 to S1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
Device: Spinal Cord Transcutaneous Stimulation
Qualifying participants of NCT06019949 (IRB #23.0570) randomized to the respiratory stimulation alone intervention group (Resp-scTS) will be invited to participate in this study to collect additional outcome measures. Overlapping assessments will be shared between the two studies. Participants in this arm will receive spinal cord stimulation at the thoracic level (T1 to T9 spinal cord levels) targeted for respiratory function. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
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.
Baroreflex Sensitivity
Baroreflex Sensitivity refers to the ability of the baroreflex mechanism in the body to sense changes in blood pressure and modulate heart rate and vascular tone accordingly. It is calculated as a linear regression of systolic blood pressure plotted against its corresponding R-R peaks on the electrocardiograph.
Time frame: 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)
Renal Artery Systolic Velocity is the velocity of blood flow in the main renal artery supplying the kidneys. It will be obtained individually for right main renal artery and left main renal artery.
Time frame: 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
Plasma Renin Activity is a biochemical blood test that measures the enzymatic activity of renin in the plasma. It is assessed by determining how effectively renin converts angiotensinogen to angiotensin I to evaluate the renin-angiotensin-aldosterone system (RAAS) activity.
Time frame: 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
The blood test for angiotensin converting enzyme (ACE) evaluates the concentration of ACE in the bloodstream, an enzyme that converts angiotensin I into angiotensin II, which helps regulate blood pressure by constricting small blood vessels.
Time frame: 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
An aldosterone blood test measures the hormone aldosterone in the blood to evaluate adrenal gland function and its impact on blood pressure and electrolyte balance.
Time frame: 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.
Complete Blood Count
This test will evaluate various components of blood including hematocrit; hemoglobin; mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH); mean corpuscular hemoglobin concentration (MCHC); red cell distribution width (RDW); percentage and absolute differential counts; platelet count (PLT); red cell count (RBC); white blood cell count (WBC) for compounding effects.
Time frame: 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.
Metabolic Panel
This test will evaluate Blood Urea Nitrogen (BUN); BUN:creatinine ratio; calcium, chloride, creatinine, eGFR; glucose; potassium and sodium to check for compounding effects.
Time frame: 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.
Lipid Panel
This test will evaluate total cholesterol, high-density lipoprotein (HDL); low-density lipoprotein (LDL); triglycerides and very low-density lipoprotein (VLDL) in blood for to check for compounding effects.
Time frame: 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.
Thyroid Panel
This test will evaluate level of thyroid hormones in the blood to check for compounding effects.
Time frame: 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.
Incidence of Orthostatic Hypotension
A pre-defined questionnaire in which participants will be asked to rate how severe their symptoms of low blood pressure are from 0 (none) to 10 (worst possible). The metrics include dizziness, lightheadedness, feeling faint, or feeling like you might black out; problems with vision (blurring, seeing spots, tunnel vision, etc.); weakness; fatigue; trouble concentrating; and head and neck discomfort.
Time frame: 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.
Plan to share: No — Plans for sharing individual participant data are currently under consideration. Decisions regarding data sharing will be made following study completion in accordance with institutional guidelines and participant privacy protections.
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