- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00357409
GABA Levels in the Brains of Blind People
GABA Levels in the Occipital Cortex of Blind Human Subjects
In blind individuals, the occipital cortex becomes capable of processing tactile and auditory information, a phenomenon described as crossmodal plasticity. GABA is the major inhibitory neurotransmitter in the brain and a possible candidate to mediate this form of human plasticity. We intend to use magnetic resonance spectroscopy (MRS) to measure GABA and hypothesize that GABA levels in the occipital cortex of blind humans will be lower than in sighted controls. Such decrease could possibly mediate compensatory changes in the occipital cortex of the blind.
Objective
Early blind subjects exhibit better tactile acuity than late blinds or sighted individuals. The purpose of the study is the determine GABA levels in the human occipital cortex after long-term light deprivation (blindness).
Study Population
Our experiments will make use of early blind, late blind, and sighted control subjects.
Design
Subject will be identified and will receive clinical and neurological examinations at the NIH. MRS studies will be performed at NIH MRI Center with 3Tesla Magnet. Each subject head will be positioned in an adjustable holder (designed for minimal motion and maximal comfort) such that a flat coil lay just below the occipital cortex. The sequence has been described before [33]. The individuals who perform the data analysis will be blind to the purpose of the experiments.
Outcome measures
The concentration of GABA from the 14 ml voxel over the visual cortex will be measured. Edited proton spectrum of GABA will be compared with the edited sub spectrum of creatine for a concentration reference.
Descripción general del estudio
Descripción detallada
In blind individuals, the occipital cortex becomes capable of processing tactile and auditory information, a phenomenon described as crossmodal plasticity. GABA is the major inhibitory neurotransmitter in the brain and a possible candidate to mediate this form of human plasticity. We intend to use magnetic resonance spectroscopy (MRS) to measure GABA and hypothesize that GABA levels in the occipital cortex of blind humans will be lower than in sighted controls. Such decrease could possibly mediate compensatory changes in the occipital cortex of the blind.
Objective
Early blind subjects exhibit better tactile acuity than late blinds or sighted individuals. The purpose of the study is the determine GABA levels in the human occipital cortex after long-term light deprivation (blindness).
Study Population
Our experiments will make use of early blind, late blind, and sighted control subjects.
Design
Subjects will be identified and will receive clinical and neurological examinations at the NIH. MRS studies will be performed at NIH MRI Center with 3Tesla Magnet. Each subject head will be positioned in an adjustable holder (designed for minimal motion and maximal comfort) such that a flat coil lay just below the occipital cortex. The sequence has been described before. The individuals who perform the data analysis will be blind to the purpose of the experiments.
Outcome measures
The concentration of GABA from the 14 ml voxel over the visual cortex will be measured. Edited proton spectrum of GABA will be compared with the edited sub spectrum of creatine for a concentration reference.
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
All subjects must be between 18 and 55 years of age.
Healthy sighted volunteers. Legally blind subjects with blindness secondary to retinal lesions or eye removal acquired at ages earlier than 4 years old (EARLY) and after 13 years of age (LATE). The rationale for the distinction is based in our previous studies that indicate different magnitude of brain plasticity depending on the age of acquisition of blindness.
EXCLUSION CRITERIA:
Exclusion criteria will be those of MRI procedures:
Pregnant women tested after urine pregnancy test.
Subjects with metal in the cranium except mouth.
Subjects with metal fragments from occupational exposure or surgical clips in or near the brain.
Subjects with blood vessel, cochlear or eye implants.
Subjects with increased intracranial pressure as evaluated by clinical means.
Subjects with cardiac or neural pacemakers.
Subjects with intracardiac lines and implanted medication pumps.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Publicaciones y enlaces útiles
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Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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
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. .