AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 (the person is 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, the investigators hope to learn how perfusion index (PI) and the other measured vital signs, respond to moving from the warm to cool room. The investigators 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).
The investigators 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 the participant arrives, the investigators will take the their temperature with an ear thermometer to make sure they don't have a fever. If the participant is having a urinary tract infection (UTI), please call before traveling to the Center. Once at the Center, the investigators will use about 30 minutes in a mildly warm room (75-80 deg F) to tape temperature sensors to the participant's forehead (to measure their body temperature). The investigators will put oxygen meters on the participant's 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). The investigators 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, the participant will remain seated in the wheelchair (or the investigators will provide them with one if they are an AB control) and will take the above measures for 10 minutes. Then, the investigators will move the participant 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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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The Bronx, New York, Estados Unidos, 10468
- Reclutamiento
- James J Peters VA Medical Center
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Investigador principal:
- Jill M Wecht, EdD
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Contacto:
- Matthew T Maher, MS
- Número de teléfono: 1706 718-584-9000
- Correo electrónico: matthew.maher@va.gov
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Contacto:
- Dylan Arnero, MA
- Número de teléfono: 5124 718-584-9000
- Correo electrónico: Dylan.Arnero@va.gov
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Sub-Investigador:
- John P Handrakis, PT, DPT, EdD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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. |
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Comparador activo: 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.
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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.
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perfusion Index (PI)
Periodo de tiempo: 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.
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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.
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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.
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Systolic Blood Pressure (SBP)
Periodo de tiempo: 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.
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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 the investigators are trying to predict to evaluate sympathetic/vascular reactivity and to train the non-invasive machine learning prediction algorithms.
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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.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1930980
- RFA # 20465 (Otro número de subvención/financiamiento: New York State Department of Health)
- SFS # PART72025 (Otro número de subvención/financiamiento: New York State Spinal Cord Injury Research Board Projects to Accelerate Research Translation (PART))
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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