Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

7. juli 2026 opdateret af: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Introduction/Background: Persons with spinal cord injury (SCI) may experience impaired control of several autonomic functions, including blood pressure (BP) fluctuations and impaired body temperature regulation in response to exercise, cold exposure, or a full bladder. Hypertension (high BP) is commonly episodic (comes and goes) and without clinical symptoms (you are unaware). Mechanisms for impaired BP regulation after SCI are not completely understood and contribute to the limited availability of reliable wearable devices for continuous BP monitoring in the community.

Purpose of the Study: By doing this research study, we hope to learn how perfusion index (PI) and the other vital signs we measure, respond to moving from the warm to cool room. We will use sophisticated analysis of the data collected, which will include artificial intelligence, to determine how perfusion index can predict changes in systolic blood pressure (SBP).

We have shown that PI can predict SBP (the greater of the 2 BP values, e.g., 120/80 mmHg) with high accuracy in animal studies of monkeys with SCI. Perfusion index can continuously measure (non-stop measuring) the blood flow in the skin using a pulse-oximeter (pulse oxygen meter) and other sensors on your skin. This new tool can help us to better understand why blood pressure is so unstable (goes quickly up and down) after SCI. The findings may also provide necessary information for developing new non-invasive and wearable devices to monitor blood pressure in the community, thereby allowing persons with SCI early detection, safety, and treatment of clinically silent high blood pressure episodes (episodes that you're not aware of).

Study Procedures: When you arrive, we will take your temperature with an ear thermometer to make sure you don't have a fever. If you are having a urinary tract infection (UTI), please call before you travel to the Center. Once at the Center, we will use about 30 minutes in a mildly warm room (75-80 deg F) to tape temperature sensors to your forehead (to measure your body temperature). We will put oxygen meters on your ear, finger and toe to measure perfusion index (PI: a ratio or percentage of blood flowing in your arteries compared to blood not flowing very much in your veins and tissues). We will place a device on another finger that measures beat-to-beat BP device (your BP of every heartbeat).

Once the instrument setup is complete, you will remain seated in your wheelchair (or we will provide you with one if you are an AB control) and we will take the above measures for 10 minutes. Then, we will move you into a cool room (64 deg F) for 90 minutes and continue the same measurements.

Impact: Our studies may provide the scientific community with a novel biomarker and tool to better understand mechanisms for unstable blood pressure control after SCI. The findings may also provide the scientific rationale for development of next-generation non-invasive and accurate and reliable wearable devices to monitor SBP in the community, thereby allowing persons with SCI early detection, safety, and treatment of clinically silent hypertensive episodes (autonomic dysreflexia: AD).

Study Aim: To determine the feasibility of PI as a novel non-invasive biomarker to predict SBP in persons with SCI during a cool temperature challenge.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • The Bronx, New York, Forenede Stater, 10468
        • Rekruttering
        • James J Peters VA Medical Center
        • Ledende efterforsker:
          • Jill M Wecht, EdD
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • John P Handrakis, PT, DPT, EdD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • You have 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)
  • You 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 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.

Exclusion Criteria:

  • You have cardiovascular, kidney, or untreated thyroid disease
  • You have a traumatic brain injury (TBI)
  • You have diabetes mellitus
  • You have an acute illness or infection
  • You are dehydrated
  • You smoke
  • You are pregnant
  • You have broken, inflamed, or otherwise fragile skin
  • Your Body Mass Index (BMI) is more than 30 kg/m2

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andet: 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.
Aktiv komparator: 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.
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perfusion Index (PI)
Tidsramme: 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.
Perfusion index (PI: ranging from 0.02 to 20) reflects the ratio of pulsatile (arterial) blood flow to non-pulsatile static blood flow. PI will be continuously collected using Masimo Radical-7 pulse oximeters (Masimo Corp., Irvine, CA) attached to three sites: an ear, a finger, and a toe. This multi-site data will serve as the primary independent predictor variable of SBP in the AI/machine learning models.
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)
Tidsramme: 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.
Beat-to-beat systolic blood pressure (SBP: mmHg) will be continuously collected via a finger-cuff sensor using the VitalStream-CM wireless hemodynamic monitor (CareTaker Medical LLC, Charlottesville, VA). SBP will serve as the primary target dependent variable that we are trying to predict to evaluate sympathetic/vascular reactivity and to train the non-invasive machine learning prediction algorithms.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

James J. Peters Veterans Affairs Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1930980
  • RFA # 20465 (Andet bevillings-/finansieringsnummer: New York State Department of Health)
  • SFS # PART72025 (Andet bevillings-/finansieringsnummer: New York State Spinal Cord Injury Research Board Projects to Accelerate Research Translation (PART))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We have an approved Data Use Agreement (DUA) with Dr. Leif Havton of the VA Puget Sound Health Care System. Transferring data to our subaward site, the VA Puget Sound Health Care System, will allow Dr Leif Havton to perform analysis of the de-identified data, which will include artificial intelligence (AI)/machine learning (ML) to determine best surrogate biomarkers for blood pressure predictions.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blodtryk

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Estonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner