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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Visual exploration training; Behavioral: Standard neuropsychological rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Zorzi; Phone Number: +39 049 827 6618; Email: marco.zorzi@unipd.it

Study Locations

• Italy
  • PD
    • Padova, PD, Italy
      • Recruiting
      • Azienda Ospedaliera di Padova
      • Contact: Andrea Zangrossi
  • VE
    • Venice-Lido, VE, Italy
      • Recruiting
      • IRCCS San Camillo
      • Contact: Valeria Camparini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking; Behavioral: Standard neuropsychological rehabilitation; Standard rehabilitation delivered at the IRCCS San Camillo hospital
Active Comparator: Control; This group will undergo the standard neuropsychological rehabilitation at the IRCCS San Camillo hospital	Behavioral: Standard neuropsychological rehabilitation; Standard rehabilitation delivered at the IRCCS San Camillo hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	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	At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Bells Test	Neuropsychological test assessing visuospatial deficits	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	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	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	At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Anosognosia	Neuropsychological test investigating deficits awareness	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	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	At day 0 and day 30 (i.e., end of the rehabilitation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change pre-post rehabilitation in structural and functional connectivity	Structural and functional MRI connectivity maps	At day 0 and day 30 (i.e., end of the rehabilitation)

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Collaborators: University of Padova; Azienda Ospedaliera di Padova
• Investigators: Principal Investigator: Marco Zorzi, San Camillo IRCCS, Venice, Italy

Publications and helpful links

General Publications

• Pollock A, Hazelton C, Henderson CA, Angilley J, Dhillon B, Langhorne P, Livingstone K, Munro FA, Orr H, Rowe FJ, Shahani U. Interventions for disorders of eye movement in patients with stroke. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD008389. doi: 10.1002/14651858.CD008389.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Visuospatial
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2020.09 RF-2019-12369300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No