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

NARecruitingINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
Spinal Cord InjuriesHypotensionOrthostatic HypotensionSpinal Cord DiseasesCardiovascular DiseasesTrauma, Nervous SystemCentral Nervous System DiseasesNervous System DiseasesBlood Pressure
Interventions
DEVICE

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."

DIAGNOSTIC_TEST

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."

Trial Locations (1)

07052

RECRUITING

Kessler Foundation, West Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kessler Foundation

OTHER

NCT05725499 - The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI) | Biotech Hunter | Biotech Hunter