NCT06841198

Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

Recruiting
NAAges 18–75InterventionalTreatment
Kessler Foundation
~15 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:spinal cord transcutaneous stimulationIce testing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systolic blood pressure in seated mapping sessions
Measured over The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
+1 more outcome measured
Spinal Cord Injuries (SCI)
Orthostatic Hypotension, Dysautonomic
Cardiovascular
Transcutaneous Spinal Stimulation
1 sites across 1 states
New Jersey1
  • Einat Engel-Haber, MD · PRINCIPAL_INVESTIGATOR · Kessler Foundation

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Eligibility criteria

Inclusion

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)
Individuals experiencing low blood pressure after the injury
American Spinal Injury Association Impairment Scale (AIS) A or B

Exclusion

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.
Injury sustained more than 6 months ago
Injury level ≥ T6 (a cervical or a high-level chest injury)
American spinal injury association impairment scale (AIS) A - D
  • Systolic blood pressure in seated mapping sessionsThe procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

    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 tiltThe procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months

    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.