Clinical trial NCT06965673: Assessment of Eye Movements in Stroke Patients and Closed-loop Intervention
Official title: Eye-movement Dynamics During Free Viewing as a Biomarker for Assessment of Visuospatial Functions and for Closed-loop Rehabilitation in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Visuospatial
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Padova
name: University of Padova
First posted: 2025-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change pre-post rehabilitation in eye movements patterns during free viewing
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Behavioral Inattention Test score
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Trail Making Test score
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Posner Test reaction times
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Attention Matrices Test
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Bells Test
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Apple Test score
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Comb and Razor Test
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Mental Number Interval Bisection
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Anosognosia
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in Load Test
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
measure: Change pre-post rehabilitation in the Catherine-Bergego Scale score
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
Secondary outcomes:
measure: Change pre-post rehabilitation in structural and functional connectivity
timeFrame: At day 0 and day 30 (i.e., end of the rehabilitation)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: PD
city: Venice-Lido
country: Italy
facility: IRCCS San Camillo
state: VE
Study officials:
affiliation: San Camillo IRCCS, Venice, Italy
name: Marco Zorzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.