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
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Among 16 studies in Autonomic Dysreflexia with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Autonomic Dysreflexia · United States.
Among the 16 studies in Autonomic Dysreflexia with a site in United States, this one is the 3rd largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 7 with no phase, and was the 16th registered.
30 studies on the registry are indexed under Autonomic Dysreflexia; 10 are open to participants now.
Browse Autonomic Dysreflexia studies →4 of the 16 studies in Autonomic Dysreflexia with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–50 · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 18–60
University of Washington · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Autonomic Dysreflexia studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 1
First in 2012; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is above the median of 22 across 23 interventional studies indexed under Autonomic Dysreflexia.
Median enrollment 13 across the 11 interventional studies, 92 across the 5 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 16 has an industry lead sponsor. The 9 most frequent:
University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
University of Louisville has 2 studies filed under Autonomic Dysreflexia — fewer than ten, so there is no comparison to draw.
2 of the studies in Autonomic Dysreflexia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07012135Mayo ClinicDeciphering Preserved Autonomic Function After Multiple Sclerosis | 2026-12-31 |
| NCT05351827VA Office of Research and DevelopmentMild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries | 2027-10-29 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Autonomic Dysreflexia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
30 studies on the registry are indexed under Autonomic Dysreflexia; 10 are open to participants now.
This study's planned enrollment of 40 is above the median of 22 across 23 interventional studies indexed under Autonomic Dysreflexia.
Browse Autonomic Dysreflexia studies →University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
Compared within Autonomic Dysreflexia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Cord Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Apr 2026 (actual). Primary completion is estimated for Feb 2029, 34 months after the start.
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