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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

This group will undergo ten sessions of the experimental visual exploration protocol and the standard neuropsychological rehabilitation delivered in the clinical facility

Group Type EXPERIMENTAL

Visual exploration training

Intervention Type BEHAVIORAL

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

Standard neuropsychological rehabilitation

Intervention Type BEHAVIORAL

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Control

This group will undergo the standard neuropsychological rehabilitation at the IRCCS San Camillo hospital

Group Type ACTIVE_COMPARATOR

Standard neuropsychological rehabilitation

Intervention Type BEHAVIORAL

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Interventions

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Visual exploration training

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

Intervention Type BEHAVIORAL

Standard neuropsychological rehabilitation

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes