Improving Visual Attention in Schizophrenia
22 de junio de 2021 actualizado por: Hans Klein, The University of Texas at Dallas
Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia
This study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Individuals with schizophrenia tend to display abnormal visual attention when performing visual tasks, typically spending less time on salient features of the stimuli (e.g. core facial features or body movement in social tasks), and instead focusing on idiosyncratic features of an image or video. Poor visual attention in schizophrenia has been directly linked to poorer social cognitive performance (e.g. recognizing emotional expressions or social cues) which can impact an individual's day to day functioning.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in schizophrenia has been demonstrated to improve a wide range of cognitive processes, and in healthy adults, tDCS has been demonstrated to improve aspects of social cognition. TDCS thus appears to be a promising therapeutic technique that may be useful for improving visual attention in patients with schizophrenia, and potentially impact social cognitive performance via an underlying mechanism tying the two. This study will compare visual performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS, while also comparing between brain stimulation sites: rTPJ and dmPFC.
Tipo de estudio
Intervencionista
Inscripción (Actual)
81
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
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Richardson, Texas, Estados Unidos, 75080
- The University of Texas at Dallas
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-
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
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e. no hospitalizations) for at least 8 weeks prior to informed consent and be on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks prior to informed consent.
Exclusion Criteria:
- The presence or history of a pervasive developmental disorder or mental retardation as defined by a premorbid IQ < 70
- Presence or history of medical or neurological disorders in which neural stimulation would be contraindicated (e.g. presence of epilepsy or history of seizures)
- Presence of sensory limitations, including visual or hearing impairments that interfere with assessment
- History of electroconvulsive therapy
- Not proficient in English
- Presence of substance abuse in the past one month or dependence not in remission in the past six months
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: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Anodal followed by sham stimulation tDCS to rTPJ
cross-over design - active stimulation tDCS to the rTPJ followed by behavioral testing.
After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing.
|
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
|
|
Comparador activo: Anodal followed by sham stimulation tDCS to dmPFC
cross-over design - active stimulation tDCS to the dmPFC followed by behavioral testing.
After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing.
|
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
|
|
Experimental: Sham followed by anodal stimulation tDCS to rTPJ
cross-over design - sham stimulation tDCS to the rTPJ followed by behavioral testing.
After 1 week delay, active stimulation tDCS to the rTPJ followed by behavioral testing.
|
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
|
|
Comparador activo: Sham followed by anodal stimulation tDCS to dmPFC
cross-over design - sham stimulation tDCS to the dmPFC followed by behavioral testing.
After 1 week delay, active stimulation tDCS to the dmPFC followed by behavioral testing.
|
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Attention to Static Faces
Periodo de tiempo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing static, emotional faces (stimuli: Emotion Recognition - 40).
AOIs for static faces will be defined as core facial features (i.e.
eyes, nose, mouth).
|
Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
|
Visual Attention to Dynamic Actor
Periodo de tiempo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Visual attention measured via eye-tracking(percentage of time attending to investigator designated AOIs) when viewing videos of a single actor (stimuli: Bell Lysaker Emotion Recognition Task).
AOIs for this task will be defined as core facial features (i.e.
eyes, nose, and mouth).
|
Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
|
Visual Attention to Dynamic Social Scenes
Periodo de tiempo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing videos of two or more actors in a scene (stimuli: The Awareness of Social Inference Task Part 3, Version A).
AOIs for this task will be defined as salient social and contextual stimuli (e.g.
social stimuli are faces of actors, while contextually salient stimuli include items actors are talking about, such as a plate full of food or an empty wallet).
|
Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fixation Stabilization
Periodo de tiempo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Stabilization of visual fixation on fixation circle positioned in middle of screen.
Participants will be placed in front of an eyetracking device and asked to keep their eyes focused on a circle in the middle of the screen.
Stabilization will be measured via eye-tracking as the deviation from a single point on screen, calculated by assessing the sum of squares of both the x and y axis (output from eyetracking device).
Higher number indicates more movement, and thus less stabilization.
|
Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hans S Klein, MS, University of Texas at Dallas
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 (Actual)
25 de marzo de 2019
Finalización primaria (Actual)
4 de marzo de 2020
Finalización del estudio (Actual)
4 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
15 de marzo de 2019
Primero enviado que cumplió con los criterios de control de calidad
15 de marzo de 2019
Publicado por primera vez (Actual)
19 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19-58
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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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