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Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Sponsor: Kessler Foundation
Summary
The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure. The main questions are: How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year? The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.
Official title: Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2025-04-01
Completion Date
2026-11
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Interventions
spinal cord transcutaneous stimulation
Stimulation, using the Neostim-5 (Cosyma Ltd.), a 5-channel electrical stimulator, will be administered throughout the study period, beginning shortly after the injury and continuing at regular intervals until one year post-spinal cord injury. It will be performed in two settings: 1. During seated mapping to identify stimulation sites (potentially T7/8, T11/12, L1/2, and S1/2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg. 2. During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms).
Locations (1)
Kessler Foundation
West Orange, New Jersey, United States