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- Ensaio Clínico NCT03880227
Improving Visual Attention in Schizophrenia
Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Richardson, Texas, Estados Unidos, 75080
- The University of Texas at Dallas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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 Ativo: 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 Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Visual Attention to Static Faces
Prazo: 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).
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Assessment will be completed 30 minutes after completion of the active/sham stimulation
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Visual Attention to Dynamic Actor
Prazo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
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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
Prazo: 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).
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Assessment will be completed 30 minutes after completion of the active/sham stimulation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Fixation Stabilization
Prazo: Assessment will be completed 30 minutes after completion of the active/sham stimulation
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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.
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Assessment will be completed 30 minutes after completion of the active/sham stimulation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hans S Klein, MS, University of Texas at Dallas
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-58
Plano para dados de participantes individuais (IPD)
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