24 Participants NeededMy employer runs this trial

Perfusion Index for Blood Pressure Prediction in Spinal Cord Injury

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: James J. Peters Veterans Affairs Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the perfusion index (PI), a measure of blood flow, can predict changes in blood pressure for people with spinal cord injuries (SCI) when exposed to cool temperatures using the Controlled Cool Thermal Challenge (18°C). Researchers will compare PI and blood pressure changes in both SCI patients and healthy individuals during the test. Ideal participants are those who have had a spinal cord injury for over a year and cannot voluntarily move their legs. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding of SCI-related blood flow issues.

What prior data suggests that this method is safe for predicting blood pressure changes in spinal cord injury patients?

A previous study tested different cooling methods on people with spinal cord injuries (SCI) and found them generally safe and comfortable. For example, ice packs and cold water effectively lowered body temperature safely. However, monitoring the body's response is crucial, as people with SCI might struggle to regulate their body temperature. They may not sweat properly below the injury, affecting their ability to handle temperature changes. Despite these challenges, cooling has helped manage heat stress without major safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to understanding blood pressure regulation in people with spinal cord injuries (SCI). Unlike traditional methods that often focus on medication or rehabilitation, this trial uses a controlled cool thermal challenge to potentially predict blood pressure changes. By examining how a drop in temperature affects the perfusion index and systolic blood pressure, researchers hope to uncover new insights into autonomic dysfunction in SCI patients. This method could pave the way for more personalized and non-invasive monitoring strategies, offering a fresh perspective compared to current treatments.

What evidence suggests that this method is effective for predicting blood pressure changes in spinal cord injury?

This trial will compare the effects of a cool temperature challenge on participants with spinal cord injuries (SCI) and able-bodied participants. Research has shown that cooling methods, such as ice packs and cold water, can increase comfort and lower body temperature in people with spinal cord injuries. One study found that cooling can also reduce the rise in body heat in athletes with spinal cord injuries. Another study showed that lowering body temperature in individuals with recent spinal cord injuries improved nerve function by more than 55%. These findings suggest that controlling body temperature through cooling might influence blood pressure changes in people with spinal cord injuries.14567

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with spinal cord injury (C4-T12, motor complete) or healthy people of similar age. Participants must be able to sit in a wheelchair and tolerate temperature changes. Both men and women can join.

Inclusion Criteria

I am between 18 and 75 years old.
If you are going to participate, you must avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to the study visit
I have had a spinal cord injury (C4-T12) for over a year and cannot move my legs.
See 1 more

Exclusion Criteria

I have diabetes.
You are pregnant
I have heart, kidney, or untreated thyroid disease.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Participants are seated in a thermoneutral room for 10 minutes to record baseline measurements of perfusion index and systolic blood pressure

10 minutes
1 visit (in-person)

Cool Temperature Challenge

Participants are moved to a cool room for up to 90 minutes to measure changes in perfusion index and systolic blood pressure

90 minutes
1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects or adverse reactions after the cool temperature challenge

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Controlled Cool Thermal Challenge (18°C)

Trial Overview

The study tests if a measurement called perfusion index (PI) can predict blood pressure changes during exposure to cool temperatures. Both people with spinal cord injuries and healthy controls will have their vital signs monitored while sitting in warm and then cool rooms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Participants with SCI: Cool temperature challengeExperimental Treatment1 Intervention
Group II: Able-bodied participants (Control): Cool temperature challengeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials
59
Recruited
2,900+

Citations

Thermodysregulation in persons with spinal cord injury - PMC

The cooling methods of ice packs over head and neck and cold water provided subjective comfort and an acute decrease in Tcore (40.1 to 38.3 °C).

Review The effect of pre-cooling or per-cooling in athletes ...

Pre- and per-cooling can attenuate the increase in thermal strain in athletes with a spinal cord injury. The beneficial effects of cooling are greater in ...

Spinal Cord Injury Complications: Temperature Regulation

Take breaks from extreme environments to help your body regulate. If temperature remains abnormal, consult a doctor to rule out other causes like infection.

Efficacy of Various Cooling Techniques During Exercise in ...

Results: ΔTC in the C and H conditions was proportional to the neurological level of injury, with Tc rising highest in the TP followed by the PP ...

Stay Safe in Hot Weather: The SCI Guide

This article will explain how spinal cord injury (SCI) can affect thermoregulation and what you can do to better manage your body temperature.

Heated Vest for Persons With Spinal Cord Injury

In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance.

Thermoregulatory Challenges In Para-Sport: Current ...

Athletes with spinal cord injuries (SCI) may have impaired sweating below the level of injury, limiting effective heat dissipation.