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.
Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
Between 18-75 years old
7-50 days after injury
Injury level ≥ T6 (a cervical or a high-level chest injury)
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).
Single group
spinal cord transcutaneous stimulation
DeviceStimulation, 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).
Ice testing
Procedure/SurgeryIce testing is performed using either a 3-minute ice-water immersion or a 3-minute ice-wrap application surrounding the foot. Each participant undergoes both the ice-water and ice-wrap conditions within the same session, separated by a 30-minute interval to allow the foot to return to baseline. Testing is conducted in both the seated and supine positions across two separate sessions, with both the cooling modality and body position randomized.
Systolic blood pressure in seated mapping sessions
Spatiotemporal mapping sessions involving stimulation of various spinal segments, utilizing different parameters (e.g., frequency, waveform). A BP response in a mapping session will be defined by a significant increase in SBP of at least 20 mmHg with stimulation compared to baseline SBP (without stimulation)
systolic blood pressure in a 70 degree tilt
In this study, tilt-tests are conducted in pairs: first, a standard tilt test (without stimulation), followed by a tilt test with stimulation aimed at preventing orthostatic hypotension. We will compare the drop in systolic blood pressure during the tilt test with stimulation to the drop observed in the standard tilt test.
cold pressor test
In a traditional cold pressor test, the foot is immersed in 0°C ice water, indirectly assessing the degree of sympathetic activation through BP and HR
24-hour ambulatory blood pressure monitoring
Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities, and their time points.
An autonomic dysfunction following spinal cord injury questionnaire
Assessing the severity and frequency of daily AD and OH episodes and their effect on daily activities
Blood pressure changes during ice testing (spin-off experiment)
Change in systolic blood pressure during ice water immersion/ice wrapping, compared to baseline
Pain response to ice testing (spin-off experiment)
VAS (Visual Analog Scale) pain ratings (a scale of 0 - no pain to 10 - worst pain) are collected every minute throughout the 3-minute ice test to quantify the pain response associated with each testing modality.
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