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Assessment of Eye Movements in Stroke Patients and Closed-loop Intervention

Eye-movement Dynamics During Free Viewing as a Biomarker for Assessment of Visuospatial Functions and for Closed-loop Rehabilitation in Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06965673
Acronym
EMS
Enrollment
30
Registered
2025-05-11
Start date
2023-04-01
Completion date
2025-06-30
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Visuospatial

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVisual exploration training

Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking

BEHAVIORALStandard neuropsychological rehabilitation

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Sponsors

Azienda Ospedaliera di Padova
CollaboratorOTHER
University of Padova
CollaboratorOTHER
IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Vigilant * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change pre-post rehabilitation in the Catherine-Bergego Scale scoreAt day 0 and day 30 (i.e., end of the rehabilitation)Test assessing activities of daily living involving spatial attention
Change pre-post rehabilitation in eye movements patterns during free viewingAt 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 Behavioral Inattention Test scoreAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Trail Making Test scoreAt 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 timesAt 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 TestAt 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 RevisedAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test assessing visuospatial memory
Change pre-post rehabilitation in Bells TestAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Apple Test scoreAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test assessing visuospatial deficits
Change pre-post rehabilitation in Comb and Razor TestAt 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 Mental Number Interval BisectionAt 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 AnosognosiaAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test investigating deficits awareness
Change pre-post rehabilitation in Load TestAt day 0 and day 30 (i.e., end of the rehabilitation)Neuropsychological test assessing spatial attentional deficits with cognitive load as a moderator

Secondary

MeasureTime frameDescription
Change pre-post rehabilitation in structural and functional connectivityAt day 0 and day 30 (i.e., end of the rehabilitation)Structural and functional MRI connectivity maps

Countries

Italy

Contacts

Primary ContactMarco Zorzi
marco.zorzi@unipd.it+39 049 827 6618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026