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

This study is exploring if non-invasive spinal cord stimulation (scTS) can help improve blood pressure control in people with chronic spinal cord injury (SCI). The scTS device, called Biostim/Neostim, uses self-adhesive electrodes placed on the skin over your spinal cord. Researchers want to see if stimulating specific areas of the spinal cord can stabilize blood pressure and affect enzymes involved in its regulation. To join, you must be at least 18 years old, have a stable medical condition, and a motor-complete SCI that is not getting worse. The study aims to enroll up to 40 participants, with a goal of 15 completing all interventions and assessments. The study's status is currently unclear.

Study design
This is an interventional study planning to enroll up to 40 participants. It will test if stimulating different sites on the spinal cord can improve blood pressure regulation.
What's involved
You would participate in 80 sessions over 16 to 20 weeks, with sessions lasting one hour, 4 to 5 days per week. You will also have several assessments before, during, and after the intervention.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 16 weeks after the intervention period, with assessments at 8 weeks and 16 weeks post-intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07504055

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

Recruiting
NAAges 18+InterventionalTreatment
University of Louisville
~40 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Spinal Cord Transcutaneous Stimulation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baroreflex Sensitivity
Measured over 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.
+4 more outcomes measured

Conditions

Spinal Cord Injury
Orthostatic Hypertension
Autonomic Dysreflexia

Explore related trials

Autonomic dysreflexiaOrthostatic HypotensionSpinal Cord Injury

Where it's being run

2 sites across 1 states
Kentucky2

Study leadership

  • Alexander Ovechkin · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Andrea M Willhite
[email protected]
1-502-581-8675
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Baroreflex SensitivityWithin 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)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 ActivityWithin 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 EnzymeWithin 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.

  • AldosteroneWithin 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.