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Идёт набор NCT06965673

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

Без фазы С лечением Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Visual exploration training, Standard neuropsychological rehabilitation.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change pre-post rehabilitation in eye movements patterns during free viewing [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Behavioral Inattention Test score [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Trail Making Test score [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Posner Test reaction times [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Attention Matrices Test [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Bells Test [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Apple Test score [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Comb and Razor Test [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
  • Change pre-post rehabilitation in Mental Number Interval Bisection [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]
Вторичные конечные точки (1)
  • Change pre-post rehabilitation in structural and functional connectivity [Срок оценки: At day 0 and day 30 (i.e., end of the rehabilitation)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Италия · 2 центра
  • Azienda Ospedaliera di Padova — Padova
  • IRCCS San Camillo — Venice-Lido

Публикации

  • 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

Идентификаторы

NCT: NCT06965673 · 2020.09 RF-2019-12369300

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗