AI-guided prediction of blood pressure changes in spinal cord injury using perfusion index during a cool-temperature test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will recruit adults with spinal cord injury (C4–T12, AIS A/B) and age- and gender-matched able-bodied controls. Participants will undergo a controlled cool temperature challenge (18°C) while continuous measurements, including perfusion index and blood pressure, are collected. The study uses AI-driven analysis to examine how changes in perfusion index relate to changes in systolic blood pressure and compares this to other vital signs. The goal is to determine if PI can serve as a biomarker for SBP fluctuations in SCI during cold exposure. Results may inform better monitoring and management of autonomic instability in SCI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant had a spinal cord injury (SCI: C4-T12) for more than one year and the SCI was graded as ASIA Impairment Scale (AIS) A or B (unable to voluntarily move your legs)
* The participant can also be a gender and age-matched (±5 years) able-bodied (AB) control subject (similar gender and age to a subject with SCI).
* Subjects with SCI and AB controls must be between 18 and 75 years of age.
* If the participant are going to do the study, they must avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to the study visit.

Exclusion Criteria:

* The participant has cardiovascular, kidney, or untreated thyroid disease
* The participant has had a traumatic brain injury (TBI)
* The participant has diabetes mellitus
* The participant has an acute illness or infection
* The participant is dehydrated
* The participant smokes
* The participant is pregnant
* The participant has broken, inflamed, or otherwise fragile skin
* The participant's Body Mass Index (BMI) is more than 30 kg/m2

Where it's running

• James J Peters VA Medical Center
  The Bronx, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.