Autonomic Dysreflexia Clinical Trials

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Effectiveness of Transcutaneous Spinal Cord Stimulation on Blood Pressure Regulation in Individuals With Chronic Spinal Cord Injury

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Kentucky

Frazier Rehabilitation and Neuroscience Institute

NOT_YET_RECRUITING

Louisville

Frazier Rehabilitation Institute

RECRUITING

Louisville

Contact Information

Primary

Andrea M Willhite

andrea.willhite@louisville.edu

1-502-581-8675

Backup

Kristin Benton

kristin.benton@louisville.edu

1-502-581-8675

Time Frame

Start Date: 2026-04-01

Estimated Completion Date: 2029-02

Participants

Target number of participants: 40

Treatments

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.

Related Therapeutic Areas

Hypertension

Autonomic Dysreflexia

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