Assessment of Eye Movements in Stroke Patients and Closed-loop Intervention
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Camillo, Venezia, Italy
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Visual exploration training
BehavioralVisual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking
Standard neuropsychological rehabilitation
BehavioralStandard rehabilitation delivered at the IRCCS San Camillo hospital
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
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)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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Camillo, Venezia, Italy
Lead sponsor
Azienda Ospedaliera di Padova
Collaborator
University of Padova
Collaborator
Source ClinicalTrials.gov