RecruitingNot ApplicableNCT05731986

Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study


Sponsor

Kessler Foundation

Enrollment

12 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

Spinal cord injuries (SCI) at or above the mid-chest level frequently damage the nerves that control blood pressure, leading to chronically low blood pressure (hypotension) and dangerous drops in blood pressure when sitting up (orthostatic hypotension). These blood pressure problems cause dizziness, fainting, and significantly delay rehabilitation. Transcutaneous spinal cord stimulation — a non-invasive technique that delivers mild electrical pulses through the skin over the spine — may help restore blood pressure regulation without medications. This study is testing whether this approach can improve blood pressure stability in the acute phase after SCI. Adults aged 18 to 75 who are 7 to 30 days after a spinal cord injury at the thoracic level T2 or above, classified as AIS A–C (meaning moderate to complete injury), and who exhibit hypotensive symptoms are eligible. Patients who are ventilator-dependent, have implanted neurostimulators or pacemakers, have significant cardiac disease, or are pregnant are excluded. Participants will receive sessions of non-invasive electrical stimulation applied to the back, and blood pressure responses will be carefully monitored. This research is important because hypotension after high spinal cord injury is a serious and poorly treated problem that worsens outcomes — if transcutaneous stimulation proves effective, it could offer a drug-free, readily applicable tool to stabilize blood pressure and accelerate rehabilitation in the critical early weeks after injury.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOrthostatic challenge

Designed to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee. This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation.

DEVICEBiostim-5 transcutaneous spinal stimulation - Mapping

Transcutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz.

DEVICEBiostim-5 transcutaneous spinal stimulation - "Optimal" testing

Based on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg).

DEVICEBiostim-5 transcutaneous spinal stimulation - "Sham" testing

Based on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.


Locations(1)

Kessler Foundation

West Orange, New Jersey, United States

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NCT05731986


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