AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury

Conditions

• Blood Pressure
• Perfusion Index
• Spinal Cord Injuries (SCI)
• Thermoregulation

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Controlled Cool Thermal Challenge (18°C) — OTHER
  Participants with SCI will undergo a controlled, non-invasive cool thermal challenge of 18°C (64.4°F) in a climate-controlled chamber for up to 90 minutes. Participants will remain seated in their wheelchair while wearing a standard T-shirt and shorts to ensure uniform skin exposure. Continuous non-invasive monitoring of perfusion index and blood pressure will be performed throughout the baseline of 27°C (80°F) and cool challenge 18°C (64.4°F) phases to evaluate their relationship.
• Controlled Cool Thermal Challenge (18°C) — OTHER
  Able-bodied participants will undergo a controlled, non-invasive cool thermal challenge of 18°C (64.4°F) in a climate-controlled chamber for up to 90 minutes. Participants will remain seated in a wheelchair that will be provided while wearing a standard T-shirt and shorts to ensure uniform skin exposure. Continuous non-invasive monitoring of perfusion index and blood pressure will be performed throughout the baseline of 27°C (80°F) and cool challenge 18°C (64.4°F) phases to evaluate their relationship.

Study Details

The goal of this clinical trial is to determine if perfusion index (PI) can reliably predict changes in systolic blood pressure (SBP) in persons with spinal cord injury (SCI) during a cool temperature challenge. Participants with SCI can be 18-75 years of age, male or female, neurological level of injury C4-T12, ASIA Impairment Scale (AIS: A or B: motor complete) or gender and healthy age-matched able-bodied (AB) controls. The main question this study aims to answer is: can PI reliably predict change in SBP during a cool temperature challenge? We hypothesize that PI can be used as a biomarker of SBP in persons with SCI. Researchers will compare the relationship of 1) changes in PI and SBP and 2) relationship of changes in other vital signs to SBP, during the cool temperature challenge. The researchers aim to determine if PI can be used as a biomarker of SBP in persons with SCI during a cool temperature challenge (experimental group/arm). Able-bodied controls (control group/arm) will receive the same intervention (cool challenge) as the experimental group. During the study, participants will be asked to wear only shorts and a T-shirt so that their skin can be exposed to the warm and cool temperatures of the 2 rooms. We will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. We will record these measurements while you are seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room.

Key Dates

First listed

Jul 13, 2026

Start date

Jul 1, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Participants with SCI: Cool temperature challenge
  Participants with SCI will be transferred from a thermoneutral room (27°C) to a cool thermal chamber (18°C) for up to 90 minutes to determine change in 1) perfusion index and 2) systolic blood pressure.
• Active Comparator: Able-bodied participants (Control): Cool temperature challenge
  Able-bodied participants will be transferred from a thermoneutral room (27°C) to a cool thermal chamber (18°C) for up to 90 minutes to determine change in 1) perfusion index and 2) systolic blood pressure.

Primary Outcome Measure

Perfusion Index (PI) [ Time Frame: Continuously recorded during 10 minutes of the baseline thermoneutral (27°C) phase and throughout the cool thermal challenge (18°C) phase for up to 90 minutes. ]

Locations (1)

Find similar trials in The Bronx, NY

Related Studies

• TSCS for Acute SCI
  Recruiting · Icahn School of Medicine at Mount Sinai · New York, New York
• Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
  Recruiting · Columbia University · New York, New York
• Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents
  Recruiting · NYU Langone Health · New York, New York
• Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
  Recruiting · Jill M. Wecht, Ed.D. · New York, New York