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

Launched by KESSLER FOUNDATION · Feb 18, 2025

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ClinConnect Summary

This clinical trial is studying how heart and blood pressure function change during the first year after a spinal cord injury. The researchers want to understand how a specific treatment called transcutaneous spinal stimulation, which involves applying gentle electrical stimulation through the skin, affects blood pressure. They will track how effective this treatment is over time, especially for individuals who experience low blood pressure after their injury.

To participate in this study, individuals must be between 18 and 75 years old, have a spinal cord injury at or above the T6 level (which affects the chest or neck), and be in the early stages of recovery (7 to 50 days after injury). Participants will be recruited during their hospital stay at the Kessler Institute for Rehabilitation and will continue with about 20-29 sessions of the study after they leave the hospital. It’s important to note that some people may not be eligible, such as those who need breathing support from a ventilator or have certain heart conditions. Overall, this trial aims to improve our understanding of cardiovascular health in individuals recovering from spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.