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TBI MR Study 3 Houston Methodist

22 de junio de 2017 actualizado por: GE Healthcare

Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3

This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.

The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.

Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor

Descripción general del estudio

Estado

Terminado

Descripción detallada

This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.

The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.

Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist Neurological Institute

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 48 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Segment 1 (mTBI patient) Inclusion and Exclusion Criteria Inclusion Criteria for mTBI subjects

Subjects included in the main part of this study (Segment 1) will:

  1. Be aged ≥15 and ≤50 years old at the time of enrollment;
  2. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the first two intervals of the study, as follows:

    1. Meets criteria for enrollment in Encounter 1 (within 72 hours), or
    2. Meets criteria for enrollment in Encounter 2 (within 8±2 days)
  3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.

Segment 1: Exclusion Criteria for mTBI subjects

Subjects will be excluded that have:

  1. Loss of consciousness (LOC) ≥15 minutes;
  2. Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
  3. Diagnosis of moderate to severe TBI or GCS <13;
  4. Structural brain injury indicated by previous neuroimaging findings;
  5. Previous history of moderate to severe TBI;
  6. Any previous history of mild TBI within the past 12 months;
  7. Previously diagnosed brain white matter disease;
  8. History of seizures within the past 10 years;
  9. History of self-reported illicit drug abuse (except marijuana) in past 10 years;
  10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  11. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
  12. History of brain mass;
  13. History of neurosurgery;
  14. History of stroke;
  15. History of dementia;
  16. Known cognitive dysfunction;
  17. Known structural brain disease or malformation;
  18. Current anti-psychotic or antiepileptic medication usage;
  19. That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
  20. Contraindications to MRI scanning, including:

    1. Current or suspected pregnancy per site clinical practice;
    2. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
    3. Inability to comply with any part of the site's MR safety policy.

Segment 2 (non-TBI subject) Inclusion and Exclusion Criteria Inclusion Criteria for Non-TBI subjects (Segment 2)

All included subjects will:

  1. Aged ≥15 and ≤50 years old at the time of enrollment;
  2. Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:

    1. Age,
    2. Gender,
    3. Sociodemographic characteristics, and
    4. Handedness.
  3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.

Exclusion Criteria for Non-TBI subjects (Segment 2)

Subjects will be excluded that:

  1. Are currently pregnant based on subject self-report of pregnancy status;
  2. Are currently enrolled in another Segment of this study;
  3. Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
  4. Prior diagnosis of mild TBI within the past 12 months;
  5. Have structural brain injury indicated by previous neuroimaging findings;
  6. Previous history of moderate to severe TBI within the past 10 years;
  7. Previously diagnosed brain white matter disease;
  8. History of seizures within the past 10 years;
  9. History of illicit drug abuse (except marijuana) within the past 10 years
  10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  11. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
  12. History of brain mass;
  13. History of neurosurgery;
  14. History of stroke;
  15. History of dementia;
  16. Known cognitive dysfunction;
  17. Known structural brain disease or malformation;
  18. Current anti-psychotic or antiepileptic medication usage;
  19. Have contraindications to MRI scanning, including:

    1. Current or suspected pregnancy per site clinical practice;
    2. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
    3. Inability to comply with any part of the site's MR safety policy.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental: mTBI de diagnóstico
Diagnóstico por resonancia magnética de sujetos con lesión cerebral tramática leve (mTBI)
Escáner de resonancia magnética disponible comercialmente que utiliza bobinas de resonancia magnética en investigación o estándar y una serie de paquetes de aplicaciones en investigación que contienen un conjunto predeterminado de secuencias de pulso de resonancia magnética
Otros nombres:
  • Imagen de resonancia magnética
Comparador de placebos: Experimental: Diagnóstico No mTBI
Diagnóstico de resonancia magnética de sujetos no lesionados que se asemejan mucho a mTBI
Escáner de resonancia magnética disponible comercialmente que utiliza bobinas de resonancia magnética en investigación o estándar y una serie de paquetes de aplicaciones en investigación que contienen un conjunto predeterminado de secuencias de pulso de resonancia magnética
Otros nombres:
  • Imagen de resonancia magnética

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progresión de mTBI indicada por características neurológicas clínicas, imágenes de resonancia magnética y datos cuantitativos de resonancia magnética de software novedoso
Periodo de tiempo: Línea de base a 3 meses
Para determinar asociaciones entre datos neurológicos clínicos, imágenes de RM, datos cuantitativos de posprocesamiento de software novedoso (software desarrollado por patrocinadores que incluye volumetría, curtosis, estado de reposo [RS], imágenes de resonancia magnética funcional [fMRI] y módulos de posprocesamiento adicionales pueden ser necesarios). proporcionó
Línea de base a 3 meses

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Joseph C Masdeu, MD. PhD, Houston Methodist Neurological Institute

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2014

Finalización primaria (Actual)

1 de mayo de 2015

Finalización del estudio (Actual)

1 de noviembre de 2015

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2014

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2014

Publicado por primera vez (Estimar)

18 de agosto de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

22 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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. .

Ensayos clínicos sobre Lesión cerebral traumática

Ensayos clínicos sobre Diagnóstico de resonancia magnética

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