An interventional study of Visual exploration training and Standard neuropsychological rehabilitation in Stroke, sponsored by IRCCS San Camillo, Venezia, Italy. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
This group will undergo ten sessions of the experimental visual exploration protocol and the standard neuropsychological rehabilitation delivered in the clinical facility
Behavioral: Visual exploration training · Behavioral: Standard neuropsychological rehabilitation
This group will undergo the standard neuropsychological rehabilitation at the IRCCS San Camillo hospital
Behavioral: Standard neuropsychological rehabilitation
Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking
Standard rehabilitation delivered at the IRCCS San Camillo hospital
Change pre-post rehabilitation in eye movements patterns during free viewing
Eye movements patterns described by fixations, saccades and blinks related features summarized by principal component analysis (PCA)
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Behavioral Inattention Test score
Neuropsychological test assessing visuospatial deficits
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Trail Making Test score
Neuropsychological test assessing visuospatial abilities, scored as the time to complete the task
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Posner Test reaction times
Neuropsychological test assessing visuospatial abilities, scored with the measured reaction times
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Attention Matrices Test
Neuropsychological test assessing visuospatial deficits
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised
Neuropsychological test assessing visuospatial memory
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Bells Test
Neuropsychological test assessing visuospatial deficits
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Apple Test score
Neuropsychological test assessing visuospatial deficits
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Comb and Razor Test
Neuropsychological test assessing functional activities to investigate spatial attention deficits
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Mental Number Interval Bisection
Neuropsychological test investigating spatial biases in the mental number line
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Anosognosia
Neuropsychological test investigating deficits awareness
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Load Test
Neuropsychological test assessing spatial attentional deficits with cognitive load as a moderator
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in the Catherine-Bergego Scale score
Test assessing activities of daily living involving spatial attention
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in structural and functional connectivity
Structural and functional MRI connectivity maps
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Plan to share: No
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IRCCS San Camillo, Venezia, Italy