- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01742858
Normative Data of Brain Network Activation
Establishment of Normative Data of Brain Network Activation Analysis (BNA) Using Evoked Response Potentials, in Adolescents and Young Adults
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.
The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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Oregon
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Eugene, Oregon, Estados Unidos, 97403
- Electrical Geodesics, Inc.
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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:
- Age 15-30 years.
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
Exclusion Criteria:
- Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
- Currently with lice or open wounds on scalp.
- Any chronic disease as determined by clinical evaluation and medical history.
- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
- Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
- History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
- History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
- Substance abuse in the last 3 months.
- Significant sensory deficits, e.g., deafness or blindness.
- History of any clinically significant brain trauma as determined by the investigator
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Adolescents
15-18 years old
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Young adults I
19-24 years old
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Young adults II
25-30 years old
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Periodo de tiempo: 1 week
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The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24, 25-30 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks
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1 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Don Tucker, PhD, Electrical Geodesics, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ELM-07
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