Eye-movement Dynamics During Free Viewing as a Biomarker for Assessment of Visuospatial Functions and for Closed-loop Rehabilitation in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change pre-post rehabilitation in Apple Test score
研究概览
简要总结
The current study evaluates first the assumption that eye-movements during free viewing behavior are potential biomarkers of visuospatial deficits in stroke population. Second, it assesses the feasibility of a novel visual exploration training to ameliorate visuospatial deficits, by exploiting an auditory biofeedback system coupled with online parsed fixations.
详细描述
This study is divided into two parts concerning the diagnostic and treatment of visuospatial deficits in patients affected by unilateral stroke. Eye movements indices during free viewing of natural scenes will be correlated to the standard neuropsychological evaluation, describing the cognitive, motor and functional spectrum of patient status. Moreover, functional and structural neuroimaging will be exploited to identify neural correlates of patient eye movements characteristics. Ultimately, a subsample of randomly assigned participants, at the IRCCS San Camillo, will undergo a novel visual exploration training, in addition to the standard rehabilitation. This protocol consists of natural scene exploration guided by an auditory biofeedback system which tracks online parsed fixations. Concretely, the training maneuvers exploration toward salient regions of the presented image, as indicated by a normative sample. Changes in free viewing behavior, neuropsychological assessment and neuroimaging will be discussed compared to an active control group and a healthy sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First unifocal ischemic or hemorragic stroke
- •Presence of maximum two lacunae, clinically silent, smaller than 15 mm. in the structural MRI
- •Evident symptoms in the visual, attentive, memory, motor or language domain supported by the radiological exam
排除标准
- •Previous stroke history, visible at the radiological exam
- •Multifocal deficit
- •Incapacity to remain vigilant during the required assessments
- •Claustrophobia and/or metallic objects which could prevent MRI acquisition
- •Presence of other neurological, psychiatric or medical conditions which may undermine interpretation of behavioral and neuroimaging results
结局指标
主要结局
Change pre-post rehabilitation in Apple Test score
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Comb and Razor Test
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing functional activities to investigate spatial attention deficits
Change pre-post rehabilitation in Trail Making Test score
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial abilities, scored as the time to complete the task
Change pre-post rehabilitation in Posner Test reaction times
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial abilities, scored with the measured reaction times
Change pre-post rehabilitation in Attention Matrices Test
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial memory
Change pre-post rehabilitation in Bells Test
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Behavioral Inattention Test score
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in eye movements patterns during free viewing
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Eye movements patterns described by fixations, saccades and blinks related features summarized by principal component analysis (PCA)
Change pre-post rehabilitation in Mental Number Interval Bisection
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test investigating spatial biases in the mental number line
Change pre-post rehabilitation in Anosognosia
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test investigating deficits awareness
Change pre-post rehabilitation in Load Test
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing spatial attentional deficits with cognitive load as a moderator
Change pre-post rehabilitation in the Catherine-Bergego Scale score
时间窗: At day 0 and day 30 (i.e., end of the rehabilitation)
Test assessing activities of daily living involving spatial attention
次要结局
- Change pre-post rehabilitation in structural and functional connectivity(At day 0 and day 30 (i.e., end of the rehabilitation))
研究者
Marco Zorzi
Professor
IRCCS San Camillo, Venezia, Italy