Recruiting

Perfusion Index

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT07699094

Conditions

Spinal Cord Injuries (SCI)

Blood Pressure

Thermoregulation

Perfusion Index

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Controlled Cool Thermal Challenge (18°C)

Controlled Cool Thermal Challenge (18°C)

Study Details

Brief summary:

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? The investigators 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.

The investigators will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. The investigators will record these measurements while the participant is seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room.

Conditions

Spinal Cord Injuries (SCI)

Blood Pressure

Thermoregulation

Perfusion Index

Study ID

NCT07699094

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Controlled Cool Thermal Challenge (18°C)

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)

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.

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. ]
  • Systolic Blood Pressure (SBP) [ 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. ]

Central Contacts and Locations

Locations

James J Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Dylan Arnero, MA

718-584-9000Dylan.Arnero@va.gov

Matthew T Maher, MS

718-584-9000matthew.maher@va.gov

Principal Investigator:

Jill M Wecht, EdD

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2026-08-10.