RecruitingNot ApplicableNCT05725499

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

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury

Sponsor

Kessler Foundation

Enrollment

5 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Central Nervous System Diseases Blood Pressure Nervous System Diseases Spinal Cord Injuries Trauma, Nervous System Spinal Cord Diseases Hypotension Orthostatic Hypotension

Summary

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transcutaneous electrical stimulation — non-invasive electrical stimulation applied to the skin on the abdomen or back — can help raise and stabilize blood pressure in people with spinal cord injury (SCI) who suffer from chronically low blood pressure (hypotension). Low blood pressure is a major quality-of-life issue for SCI patients and can cause dizziness, fainting, and limit independence. You may be eligible if: - You are 18 to 75 years old - You have had a spinal cord injury for at least 6 months - Your injury is at or above the T6 spinal level (thoracic level) - Your injury is classified ASIA A through D - You experience at least one of: resting blood pressure below 90 mmHg, a significant drop in blood pressure when sitting up, or symptoms of orthostatic hypotension You may NOT be eligible if: - You have an active illness, pressure injury, recent DVT/PE, or infection - You are ventilator-dependent - You have an implanted brain, spine, or nerve stimulator - You have a cardiac pacemaker, defibrillator, or intra-cardiac lines - You have a recent myocardial infarction or serious heart disease - You are pregnant or have cancer Talk to your doctor to see if this trial is right for you.

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

DEVICEBiostim-5 transcutaneous spinal stimulator

Transcutaneous stimulation of the spinal cord. Mapping will be performed to determine sites for optimal modulation of blood pressure. During each mapping day, with participants in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C5/6, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increased in 5 mA increments up to 100 mA. The frequency will be 2 or 30 Hz. Profiles will be established to guide selection of optimal site locations for blood pressure modulation. The profile chosen will be used during training and testing. During testing, stimulation will be applied using the selected profile in order to normalize SBP to the range of 110-120 mmHg and stabilize it within this range during a 30-min tilt test. On each session during the 2-week training-period, stimulation will be applied for 30 minutes using the selected profile, while the participant remains in a seated position.

DIAGNOSTIC_TESTTilt-table orthostatic stress testing

While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During some of the sessions, the tilt test will be accompanied by spinal stimulation.

Locations(1)

Kessler Foundation

West Orange, New Jersey, United States

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NCT05725499

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