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RecruitingNCT06965673EMSUpdated May 11, 2025

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

An interventional study of Visual exploration training and Standard neuropsychological rehabilitation in Stroke, sponsored by IRCCS San Camillo, Venezia, Italy. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 2 years after the study started (first participant enrolled Apr 2023, registered Apr 2025).
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Visuospatial
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Behavioral: Standard neuropsychological rehabilitation

  • Active comparator
    Control

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

    Behavioral: Standard neuropsychological rehabilitation

Interventions

  • BehavioralVisual exploration training

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

  • BehavioralStandard neuropsychological rehabilitation

    Standard rehabilitation delivered at the IRCCS San Camillo hospital

06

What researchers measure

Primary outcomes

  1. 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)

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

  2. Change pre-post rehabilitation in Behavioral Inattention Test score

    Neuropsychological test assessing visuospatial deficits

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

  3. Change pre-post rehabilitation in Trail Making Test score

    Neuropsychological test assessing visuospatial abilities, scored as the time to complete the task

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

  4. Change pre-post rehabilitation in Posner Test reaction times

    Neuropsychological test assessing visuospatial abilities, scored with the measured reaction times

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

  5. Change pre-post rehabilitation in Attention Matrices Test

    Neuropsychological test assessing visuospatial deficits

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

  6. Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised

    Neuropsychological test assessing visuospatial memory

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

  7. Change pre-post rehabilitation in Bells Test

    Neuropsychological test assessing visuospatial deficits

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

  8. Change pre-post rehabilitation in Apple Test score

    Neuropsychological test assessing visuospatial deficits

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

  9. Change pre-post rehabilitation in Comb and Razor Test

    Neuropsychological test assessing functional activities to investigate spatial attention deficits

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

  10. Change pre-post rehabilitation in Mental Number Interval Bisection

    Neuropsychological test investigating spatial biases in the mental number line

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

  11. Change pre-post rehabilitation in Anosognosia

    Neuropsychological test investigating deficits awareness

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

  12. Change pre-post rehabilitation in Load Test

    Neuropsychological test assessing spatial attentional deficits with cognitive load as a moderator

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

  13. Change pre-post rehabilitation in the Catherine-Bergego Scale score

    Test assessing activities of daily living involving spatial attention

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

Secondary outcomes

  1. Change pre-post rehabilitation in structural and functional connectivity

    Structural and functional MRI connectivity maps

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

07

Study locations

2 of 2 sites recruiting
08

References and documents

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. PubMed 21975780 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Jun 2025, 26 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 26 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2025
First posted
May 11, 2025
StartActual
Apr 1, 2023
Primary completionEst.
Jun 2025
CompletionEst.
Jun 2025
Last update
May 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06965673
Lead sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Azienda Ospedaliera di Padova, University of Padova
Responsible party
Marco Zorzi (Professor, IRCCS San Camillo, Venezia, Italy) — Principal investigator
First posted
May 11, 2025
Start date
Apr 1, 2023
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
May 11, 2025

Study contacts

Marco Zorzi
Contact
marco.zorzi@unipd.it
+39 049 827 6618
Marco Zorzi
principal investigator · San Camillo IRCCS, Venice, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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