StrokeEMSNCT06965673
Assessment of Eye Movements in Stroke Patients and Closed-loop Intervention
A study testing Visual exploration training and Standard neuropsychological rehabilitation in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Visual exploration training and Standard neuropsychological rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera di Padova
Padova, PD
Andrea Zangrossi
- Recruiting
IRCCS San Camillo
Venice-Lido, VE
Valeria Camparini
About this study
Official title: 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.
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.
- Conditions
- Stroke
- Being tested
- Visual exploration training, Standard neuropsychological rehabilitation
- Keywords
- Visuospatial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual exploration trainingBehavioural
Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking
Standard neuropsychological rehabilitationBehavioural
Standard rehabilitation delivered at the IRCCS San Camillo hospital
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will undergo ten sessions of the experimental visual exploration protocol and the standard neuropsychological rehabilitation delivered in the clinical facility Receives: 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 Receives: Behavioral: Standard neuropsychological rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Bells Test
Neuropsychological test assessing visuospatial deficits
Measured: 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
Measured: 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
Measured: 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
Measured: At day 0 and day 30 (i.e., end of the rehabilitation)
Change pre-post rehabilitation in Anosognosia
Neuropsychological test investigating deficits awareness
Measured: 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
Measured: 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
Measured: 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
Measured: At day 0 and day 30 (i.e., end of the rehabilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Apr 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova, University of Padova
- Responsible party
- Principal investigator, Marco Zorzi, IRCCS San Camillo, Venezia, Italy
- Investigators
- Marco Zorzi, Principal investigator, San Camillo IRCCS, Venice, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965673
- Sponsor's protocol ID
- 2020.09 RF-2019-12369300
- Acronym
- EMS
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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;2011(10):CD008389. doi: 10.1002/14651858.CD008389.pub2.
PubMed 21975780
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-movement Dynamics During Free Viewing as a Biomarker for Assessment of Visuospatial Functions and for Closed-loop Rehabilitation in Stroke
- ClinicalTrials.gov ID
- NCT06965673
- Acronym / sponsor ID
- EMS / 2020.09 RF-2019-12369300
- Conditions
- Stroke
- Keywords
- Visuospatial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova, University of Padova
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Visual exploration training, Behavioral: Standard neuropsychological rehabilitationThis group will undergo ten sessions of the experimental visual exploration protocol and the standard neuropsychological rehabilitation delivered in the clinical facility |
| Control | Active comparator | Behavioral: Standard neuropsychological rehabilitationThis group will undergo the standard neuropsychological rehabilitation at the IRCCS San Camillo hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual exploration trainingVisual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking | Behavioural | Intervention |
| Standard neuropsychological rehabilitationStandard rehabilitation delivered at the IRCCS San Camillo hospital | Behavioural | Control, Intervention |
Primary outcome
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)
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
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
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
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
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
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
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
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
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
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
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
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
1 secondary outcome
Change pre-post rehabilitation in structural and functional connectivity
Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Background: PubMed 21975780Pollock 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;2011(10):CD008389. doi: 10.1002/14651858.CD008389.pub2.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Zorzi principal investigator
San Camillo IRCCS, Venice, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual exploration training and Standard neuropsychological rehabilitation in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Zorzi (+39 049 827 6618, marco.zorzi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.