Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
Kessler Foundation
5 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Between 18-75 years old
- -50 days after injury
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- Individuals experiencing low blood pressure after the injury
- American Spinal Injury Association Impairment Scale (AIS) A or B
Exclusion Criteria7
- A ventilator is needed for breathing.
- Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
- There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
- A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
- There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
- There is a history of seizures.
- Pregnancy.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06841198