El Índice de Perfusión como un Nuevo Biomarcador para la Disregulación de la Presión Arterial en Lesiones de la Médula Espinal
Este estudio tiene como objetivo recopilar datos sobre el Índice de Perfusión y la Presión Arterial Sistólica de individuos con lesiones de médula espinal, utilizando esta información para desarrollar un modelo de aprendizaje automático para predecir la disregulación de la presión arterial.
Controlled Cool Thermal Challenge (18°C)
+ Controlled Cool Thermal Challenge (18°C)
Enfermedades del Sistema Nervioso Central+2
+ Enfermedades del sistema nervioso
+ Enfermedades de la médula espinal
Estudio de Ciencia Básica
Resumen
Fecha de inicio: 1 de julio de 2026
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Ciencia Básica
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
James J Peters VA Medical Center
The Bronx, United StatesAbrir James J Peters VA Medical Center en Google Maps