Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for Emergency Department Patients With Glasgow Coma Scale 15 Traumatic Brain Injury (PIONEER-Prognosis)
Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The PIONEER-Prognosis Study is a prospective, multicenter, observational cohort study of adults aged 18 to 65 years who present to the emergency department (ED) within 24 hours of a mild traumatic brain injury (TBI) and have a Glasgow Coma Scale (GCS) score of 15, meaning they are fully alert. Although these injuries are classified as mild, up to half of such patients report persistent symptoms such as headaches, cognitive difficulties, and mood disturbances a year after injury, and clinicians currently lack a reliable way to predict, at the time of the ED visit, which patients will recover fully and which will not.
This study will apply a new classification framework proposed by the National Institute of Neurological Disorders and Stroke (NINDS), called Clinical, Biomarker, Imaging, and Modifiers (CBI-M). This framework combines clinical findings; blood tests for two brain injury proteins, glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1); results of any head computed tomography (CT) scan performed as part of routine care; and psychosocial and environmental factors. The study will evaluate how well this framework predicts recovery.
A total of 500 participants will be enrolled from five EDs in Michigan, Oregon, and California that already use GFAP and UCH-L1 blood tests in clinical care. Participants will provide a blood sample and clinical information during their ED visit, wear a WHOOP wearable device continuously for 90 days to record heart rate, heart rate variability, sleep, and physical activity, complete a brief daily symptom survey through the device application, and complete additional symptom and sleep questionnaires by email or phone at 1 week, 1 month, and 2 months.
Trained interviewers from a central outcomes team will contact participants by telephone at 14 and 90 days to assess functional recovery using the Glasgow Outcome Scale-Extended (GOS-E), along with symptoms, cognition, life satisfaction, post-traumatic stress symptoms, and resilience.
The primary outcome is complete functional recovery, defined as a GOS-E score of 8 at 90 days. The study does not assign any treatment; participants receive standard ED care. Findings are intended to improve prognostic accuracy, patient counseling, and follow-up care for the largest subgroup of patients with TBI. The prediction models developed will be made available as a free web-based tool. The study is funded by the U.S. Department of Defense and is expected to take approximately 4 years to complete, with each participant followed for 3 months.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Devon Newman, MS
- Número de teléfono: 734-764-1602
- Correo electrónico: devonn@med.umich.edu
Ubicaciones de estudio
-
-
California
-
Torrance, California, Estados Unidos, 90509
- Harbor-UCLA Medical Center
-
Contacto:
- Yesenia Perez
- Número de teléfono: 7472103472
- Correo electrónico: yperez@dhs.lacounty.gov
-
Investigador principal:
- Kabir Yadav, MD, MS, MSHS,
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
-
Contacto:
- Devon Newman, MS
- Número de teléfono: 734-763-1702
- Correo electrónico: devonn@med.umich.edu
-
Investigador principal:
- Frederick Korley, MD, PhD
-
Clinton Township, Michigan, Estados Unidos, 48038
- Henry Ford Macomb
-
Investigador principal:
- Joseph Miller, MD, MS
-
Contacto:
- Kathleen Mays-Wilson
- Número de teléfono: 313-916-9551
- Correo electrónico: Kwilso10@hfhs.org
-
Detroit, Michigan, Estados Unidos, 48202 ·
- Henry Ford Hospital
-
Investigador principal:
- Joseph Miller, MD, MS
-
Contacto:
- Kathleen Mays-Wilson
- Número de teléfono: 313-916-9551
- Correo electrónico: Kwilso10@hfhs.org
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239-3098
- Oregon Health & Science University
-
Contacto:
- Maja Strusinska-Thayer
- Número de teléfono: (503) 418-2713
- Correo electrónico: strusins@ohsu.edu
-
Investigador principal:
- Bori Kea, MD, MCR
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients aged 18 to 65 years at the time of enrollment who present to participating emergency departments (EDs) with suspected traumatic brain injury (TBI) meeting the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria and a Glasgow Coma Scale (GCS) score of 15. Key exclusion criteria include pre-existing neurological disability resulting in a pre-injury Glasgow Outcome Scale-Extended (GOS-E) score <8, high risk of loss to follow-up (e.g., no reliable phone, homelessness, incarceration, or ward of the state), pregnancy, and inability to speak English or Spanish
Descripción
Inclusion Criteria:
-
Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria.
-
Enrollment within 24 hours of injury.
-
Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment.
-
Consent to study procedures, including:
- Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1).
- Continuous use of a health-monitoring device for 3 months.
- Follow-up assessments by telephone at 14 days and 90 days.
- Completion of a daily symptom inventory via WHOOP/smartphone.
Exclusion Criteria:
- Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score <8 if assessed before the injury.
- High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state.
- Pregnancy at the time of enrollment.
- Inability to speak English or Spanish, which would prevent completion of the required assessments.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
GCS 15 TBI patients
Patients presenting to a study emergency department with a Glasgow Coma Scale (GCS) score of 15 and traumatic brain injury (TBI). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional recovery
Periodo de tiempo: 3 months
|
Functional recovery will be assessed using the Glasgow Outcome Scale-Extended (GOS-E). The GOS-E rates patient status on one of eight levels. The minimum score is 1 and the maximum score is 8: 1 = death; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; and 8 = upper good recovery. |
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Daily symptom burden
Periodo de tiempo: Up to 90 days
|
Daily symptom burden will be measured using five commonly endorsed items-fatigue, headache, poor concentration, frustration, and sleep problems-from the Rivermead Post-Concussion Questionnaire (RPQ), a validated instrument that assesses post-concussive symptom severity. Each symptom is rated from 0 to 4, with 0 indicating that the symptom is not experienced and 4 indicating a severe problem. Scores for the five items are summed to yield a total score ranging from 0 to 20, with higher scores indicating greater daily post-concussive symptom burden. |
Up to 90 days
|
|
Heart rate variability (HRV)
Periodo de tiempo: Up to 90 days
|
HRV will be continuously measured using the WHOOP wearable device. HRV will be reported in milliseconds (ms) and reflects variation in the time intervals between successive heartbeats. HRV is a continuous physiological measure with no predefined minimum or maximum value. Higher or lower HRV values are not inherently classified as better or worse outcomes; values will be evaluated as physiological measures in relation to recovery following traumatic brain injury. |
Up to 90 days
|
|
Resting heart rate (rHR)
Periodo de tiempo: Up to 90 days
|
Physiological outcomes will be continuously measured via the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics |
Up to 90 days
|
|
Sleep patterns - Sleep duration
Periodo de tiempo: Up to 90 days
|
Sleep duration will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Sleep patterns - Sleep efficiency
Periodo de tiempo: Up to 90 days
|
Sleep efficiency will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Sleep patterns - Sleep latency
Periodo de tiempo: Up to 90 days
|
Sleep latency will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Sleep patterns - Total amount of sleep
Periodo de tiempo: Up to 90 days
|
Total amount of sleep will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Sleep patterns - percentage of restorative sleep
Periodo de tiempo: Up to 90 days
|
Percentage of restorative sleep will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Strain
Periodo de tiempo: Up to 90 days
|
Strain will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Body temperature
Periodo de tiempo: Up to 90 days
|
Body temperature will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. ClinicalTrials.gov PRS_ Protoco… |
Up to 90 days
|
|
Oxygen saturation
Periodo de tiempo: Up to 90 days
|
Oxygen saturation will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. |
Up to 90 days
|
|
Rivermead Post-Concussion Questionnaire score
Periodo de tiempo: Up to 2 months
|
Post-concussive symptoms will be assessed using the Rivermead Post-Concussion Questionnaire (RPQ). The RPQ assesses 16 common post-concussive symptoms, with each symptom rated from 0 to 4, where 0 indicates that the symptom is not experienced, 1 indicates no more of a problem than before the injury, and 2-4 indicate mild, moderate, or severe problems, respectively. For standard scoring, responses of 1 are scored as 0, resulting in a total score ranging from 0 to 64. Higher scores indicate greater post-concussive symptom burden and therefore a worse outcome. |
Up to 2 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frederick Korley, MD, PhD, University of Michigan
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
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00284360
- HT942524TBIPHRPFPA (Otro número de subvención/financiamiento: Department of Defense- Defense Health Program)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data collected during this study may be retained for future secondary analyses and will be shared in accordance with applicable U.S. Department of Defense (DoD) data-sharing policies and requirements.
Marco de tiempo para compartir IPD
Data will be made available in accordance with applicable DoD policies and requirements.
Criterios de acceso compartido de IPD
Access to study data will be provided in accordance with applicable DoD policies and requirements, including any required data use agreements or other applicable protections.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .