12
Participants
Start Date
December 1, 2023
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Orthostatic 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."
Biostim-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.
"Biostim-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).
"Biostim-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.
RECRUITING
Kessler Foundation, West Orange
Lead Sponsor
Kessler Foundation
OTHER