- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02218216
TBI MR Study 3 Houston Methodist
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
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Neurological Institute
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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:
- Be aged ≥15 and ≤50 years old at the time of enrollment;
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:
- Meets criteria for enrollment in Encounter 1 (within 72 hours), or
- Meets criteria for enrollment in Encounter 2 (within 8±2 days)
- 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:
- Loss of consciousness (LOC) ≥15 minutes;
- Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
- Diagnosis of moderate to severe TBI or GCS <13;
- Structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI;
- Any previous history of mild TBI within the past 12 months;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of self-reported illicit drug abuse (except marijuana) in past 10 years;
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- 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):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
- 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;
Contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- 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:
- Aged ≥15 and ≤50 years old at the time of enrollment;
Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
- Age,
- Gender,
- Sociodemographic characteristics, and
- Handedness.
- 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:
- Are currently pregnant based on subject self-report of pregnancy status;
- Are currently enrolled in another Segment of this study;
- Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
- Prior diagnosis of mild TBI within the past 12 months;
- Have structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI within the past 10 years;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of illicit drug abuse (except marijuana) within the past 10 years
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- 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):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
Have contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- Inability to comply with any part of the site's MR safety policy.
Plan de estudios
¿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)
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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:
|
Comparador de placebos: Experimental: Diagnóstico No mTBI
Diagnóstico de resonancia magnética de sujetos no lesionados que se asemejan mucho a mTBI
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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:
|
¿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
Patrocinador
Investigadores
- Investigador principal: Joseph C Masdeu, MD. PhD, Houston Methodist Neurological Institute
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
- 114-2014-GES-0046
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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