- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01730560
Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach (VISIOTRAIN)
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.
In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.
The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Saint Genis Laval, Francia, 69235
- Service de Médecine Physique et de Réadaptation,Hôpital Henry Gabrielle
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male/Female
- Stroke (ischemia or hemorrhage) documented by CTscan or MRI
- Traumatic brain injury (TBI) documented by CTscan or MRI
- Right or Left hemianopia defined by perimetry
- All subjects must be between the ages of 18-80
- Aetiology of visual field defect : Stroke (ischemia or hemorrhage)
- Delay post-stroke : at least 6 months
- Only one lesion on CTscan or MRI (performed in a maximal delay of 6 months)
- Corrected monocular visual acuity > 5/10
- Possible understanding of experimental conditions
- Patient being able to be quiet and sit during at least 2 hours
- Having given written informed consent prior to any procedure related to the study
- Availability for the period of the study
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
Exclusion Criteria:
- Ophthalmologic criteria : monocular visual acuity < 4/10, strabismus , diplopia , ocular instability , nystagmus, maculopathy , glaucoma , retinopathy , orthoptic rehabilitation
- Neurologic criteria : sever phasic disturbances , neurologic degenerative affection , non controlled seizure , severe handicap non compatible with prolonged sit position or concentration during 30 consecutive minutes
- No command of french language
- Non stabilized medical situation
- Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
- Not under any administrative or legal supervision
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm 1:Treatment A
Treatment A (active) followed by treatment B (neutral)
|
The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible. The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly. Each treatment phase has the same pattern:
|
Experimental: Arm 2: Treatment B
Treatment B (neutral) followed by treatment A (active)
|
Placebo treatment using the same computer-based training task, but including only the ramp phase. Each treatment phase has the same pattern:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).
Periodo de tiempo: 1 week
|
1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Errors and omissions at each evaluation session for the visual search task
Periodo de tiempo: 1, 2 and 5 weeks
|
Mean RT difference, errors and omissions at several visual tasks (rapid scanning task, exploratory visual tasks, reading task) at each evaluation session Parameters of visual field perimetry before and after treatment Oculo-motor parameters during the different tasks (i.e.
amplitude and latencies for saccades and fixations)
|
1, 2 and 5 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sophie Jacquin-Courtois, MD, PhD, Service de Médecine Physique et de Réadaptation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- 2010.615
- 2010-A00702-37 (Otro identificador: ID-RCB)
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 Treatment A
-
University of OklahomaTerminadoAumento de peso | Trastorno de alimentación Neonatal | Lactante de muy bajo peso al nacerEstados Unidos