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NCT Number: NCT06965673

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera di Padova, Padova, PD, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual exploration training

Behavioral

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

Standard neuropsychological rehabilitation

Behavioral

Standard rehabilitation delivered at the IRCCS San Camillo hospital

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Zorzi

CONTACT

[email protected]

+39 049 827 6618

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Collaborators

  • Azienda Ospedaliera di Padova
  • University of Padova

Registry information

Official study title

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

Acronym: EMS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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