Recruiting

Spinal Cord Stimulation

Sponsor:

University of Louisville

Code:

NCT07504055

Conditions

Spinal Cord Injury

Orthostatic Hypertension

Autonomic Dysreflexia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Transcutaneous Stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injury

Orthostatic Hypertension

Autonomic Dysreflexia

Study ID

NCT07504055

Start date

Apr 1, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CV-scTS 1

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.

active comparator: CV-scTS 2

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.

active comparator: Resp-scTS

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.

Interventions

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 measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Andrea M Willhite

1-502-581-8675andrea.willhite@louisville.edu

Kristin Benton

1-502-581-8675kristin.benton@louisville.edu

Locations

Frazier Rehabilitation Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Andrea Willhite, MS

502-582-8675andrea.willhite@louisville.edu

Principal Investigator:

Alexander V Ovechkin, MD, PhD

More Information

Sponsor

University of Louisville

Last update posted

Apr 28, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-04-28.