- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01552577
The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury (RETINA)
Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study will evaluate a novel method of neurocognitive assessment using computerized eye tracking. This method involves looking at targets on a computer screen while an eye-tracking system records eye movements and changes in pupil diameter in response to the presentation of the targets.
Performance on the eye tracking measures will be evaluated to identify potential effects of neural injury on cognitive performance. Data from individuals with and without a history of brain injury will be used to standardize the eye tracking measure.
Participants will also complete a short interview and several self report measures, including information about demographic characteristics, medical history, and psychological symptoms, along with a series of neuropsychological/cognitive measures that are already well established. Performance on eye tracking measures will then be compared to performance on these conventional cognitive tests to allow comparison of the different measures.
All participants will complete one visit to the laboratory at USUHS in Bethesda, MD. This visit will take approximately 2.5 hours. Participants without a history of TBI may be asked to return for a 30 minute follow-up session in order to measure the reliability of the eye tracking system. Participants with a history of TBI will complete a 10 minute telephone follow-up 6 and 12 months after their visit.
Compensation is available for civilians who are not employed by the Federal government.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20814
- USUHS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria (Control Group):
- 18 years of age or older
- No history of brain injury or concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
Exclusion Criteria (Control Group)
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis)
- History of any neurological conditions such as brain tumor, brain infection, seizure or stroke
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
Inclusion Criteria (TBI Group):
- 18 years of age or older
- History of one or more brain injuries / concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
Exclusion Criteria (TBI Group)
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis), other than TBI
- History of any neurological conditions (such as brain tumor, brain infection, seizure or stroke) that was NOT associated with or resulting from traumatic brain injury
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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TBI Group
Adults (civilian or military) with a history of one or more brain injuries / concussions.
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Control Group
Healthy adults (civilian or military) with no history of brain injury.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Performance on the eye tracking measures
Periodo de tiempo: Baseline
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Psychological symptoms
Periodo de tiempo: Baseline
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Baseline
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Performance on the neurocognitive assessment battery
Periodo de tiempo: Baseline
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Baseline
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Post-concussive symptoms
Periodo de tiempo: Baseline (and telephone follow-up, for TBI group)
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Baseline (and telephone follow-up, for TBI group)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Ettenhofer, Ph.D, Uniformed Services University of the Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- R072LP-SS3
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