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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT05725499
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biostim-5 transcutaneous spinal stimulator — DEVICE
    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 — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2023
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with a chronic SCI (≥ 6 months after injury)
    Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation)

Primary Outcome Measure

Optimal stimulation sites [ Time Frame: Through Mapping and testing sessions, average of 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
LeighAnn Martinez, BA
[email protected]
973-324-3557
Einat Engel-Haber, MD
[email protected]
Gail F Forrest, PhD (PRINCIPAL_INVESTIGATOR)
Steven Kirshblum, MD (SUB_INVESTIGATOR)
Einat Engel-Haber, MD (SUB_INVESTIGATOR)

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By research site
Kessler Foundation· West Orange, NJ

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