Menu
Recruiting NCT06965673

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual exploration training, Standard neuropsychological rehabilitation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Visual exploration training
    Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking
  • Behavioral Standard neuropsychological rehabilitation
    Standard rehabilitation delivered at the IRCCS San Camillo hospital

Primary outcome measures

  • 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)]
  • Change pre-post rehabilitation in Behavioral Inattention Test score [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Trail Making Test score [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Posner Test reaction times [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Attention Matrices Test [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Bells Test [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Apple Test score [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Comb and Razor Test [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Mental Number Interval Bisection [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]
Secondary outcome measures (1)
  • Change pre-post rehabilitation in structural and functional connectivity [Time frame: At day 0 and day 30 (i.e., end of the rehabilitation)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 2 centers
  • Azienda Ospedaliera di Padova — Padova
  • IRCCS San Camillo — Venice-Lido

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. PMID 21975780

Identifiers

NCT: NCT06965673 · 2020.09 RF-2019-12369300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗