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

NCT06965673 | Recruiting

• 1 other identifier: 2020.09 RF-2019-12369300
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Visuospatial

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Change pre-post rehabilitation in structural and functional connectivity

  At day 0 and day 30 (i.e., end of the rehabilitation)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Behavioral: Standard neuropsychological rehabilitation

Interventions

Visual exploration training BEHAVIORAL

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

Intervention

Standard neuropsychological rehabilitation BEHAVIORAL

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Azienda Ospedaliera di Padova: collaborator
• University of Padova: collaborator

Study Sites (2)

Azienda Ospedaliera di Padova

Padua, PD, Italy

RECRUITING

IRCCS San Camillo

Venice-Lido, VE, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 21975780 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marco Zorzi

  San Camillo IRCCS, Venice, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Zorzi

CONTACT

+39 049 827 6618; marco.zorzi@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)