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AI and a pulse oximeter may predict dangerous blood pressure swings in spinal cord injury

NCT ID NCT07699094

Knowledge-focused Sponsor: James J. Peters Veterans Affairs Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study explores whether a measure called perfusion index (PI), taken from a pulse oximeter on the ear, finger, or toe, can reliably predict changes in blood pressure in people with spinal cord injury (SCI) during a cool temperature challenge. Participants with SCI and healthy controls sit in a warm room then a cool room while sensors monitor their vital signs. The goal is to train an AI model to use PI as an early warning sign for blood pressure dysregulation, which is common and dangerous in SCI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a non-invasive way to predict and manage blood pressure problems in people with spinal cord injury.
What could go wrong
This is a small, early-stage observational study with only 24 participants. The findings may not apply to all people with spinal cord injury, and the AI predictions may not be accurate enough for clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood pressure Perfusion index Spinal cord injuries (SCI) Thermoregulation

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • James J Peters VA Medical Center

    RECRUITING

    The Bronx, New York, 10468, United States

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