NCT07504055 · University of Louisville
Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
What this study 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.
View original scientific description
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 outcome measures
Baroreflex Sensitivity
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.
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.
Renal Artery Systolic Velocity (Right and Left)
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 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.
Plasma Renin 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.
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.
Angiotensin Converting Enzyme
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.
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.
Aldosterone
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Louisville, Kentucky
Collaborators
Kentucky Spinal Cord and Head Injury Research Board
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations