Меню
Идёт набор NCT05061953

Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

— Наблюдательное Multiple Sclerosis

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: Eye-Tracking.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.

Вмешательства

  • Устройство Eye-Tracking
    Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Первичные конечные точки

  • Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48 [Срок оценки: Baseline and Month 48]
Вторичные конечные точки (3)
  • Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 48 [Срок оценки: Baseline and Month 48]
  • Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 48 [Срок оценки: Baseline and Month 48]
  • Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 48 [Срок оценки: Baseline and Month 48]

Критерии участия

Критерии включения

  • Able to provide informed consent.
  • Aged 18 years or older at the time of enrollment.
  • Able to read in either French or English.
  • Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc.

are permitted)

For patients only:

  • Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.
  • Neurological condition is medically stable during the study visit.
  • Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.

Критерии исключения

  • Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control.
  • Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  • Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
  • Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.

For healthy controls only:

  • Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.

For MS patients only

  • Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).
  • Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event (McDonald et al. 2001). The abnormality must have been present for at least 24 hours and occurred in the absence of fever (< 37.5°C) or known infection.
  • Patients who have been undergoing disease-modifying therapy for less than three months

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 2 центра
  • The Neuro — Montreal
  • Genge Partners, Inc. — Montreal

Идентификаторы

NCT: NCT05061953 · ETNA-ProgMS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗