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

May 1, 2025 updated by: Marco Zorzi, IRCCS San Camillo, Venezia, Italy

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change pre-post rehabilitation in eye movements patterns during free viewing
Time Frame: At 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)
At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Behavioral Inattention Test score
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test assessing visuospatial memory
At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Bells Test
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Neuropsychological test investigating deficits awareness
At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Load Test
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
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
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Test assessing activities of daily living involving spatial attention
At day 0 and day 30 (i.e., end of the rehabilitation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change pre-post rehabilitation in structural and functional connectivity
Time Frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Structural and functional MRI connectivity maps
At day 0 and day 30 (i.e., end of the rehabilitation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Camillo, Venezia, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Padova
Azienda Ospedaliera di Padova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco Zorzi, San Camillo IRCCS, Venice, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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