5
Participants
Start Date
February 1, 2023
Primary Completion Date
August 1, 2026
Study Completion Date
August 1, 2026
Biostim-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."
Tilt-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."
RECRUITING
Kessler Foundation, West Orange
Lead Sponsor
Kessler Foundation
OTHER