Меню
Набор скоро начнётся NCT07141719

Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker

— Наблюдательное Geriatric Parkinsons Disease (PD) Progressive Supranuclear Palsy(PSP) Neurological Diseases or Conditions

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Geriatric, Parkinsons Disease (PD), Progressive Supranuclear Palsy(PSP), Neurological Diseases or Conditions. 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
Германия
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 →

Официальное название

A Digital Protocol for Neurological Examination Using Eye-Tracking

Обзор

The neurological examination (NE) is a cornerstone of clinical neurology, with ocular motor assessment being a key component. Technology offers an opportunity to augment and standardize parts of the NE. Eye-tracking systems provide objective quantitative data on eye movements by continuously tracking the eye over time. This data can be used to derive parameters like saccadic latency, gaze velocity, and fixation stability with a precision that is impossible to achieve through human observation by neurologists. The integration of such technology could enhance the traditional NE. Before such technology can be widely adopted, its feasibility and acceptability in a clinical population must be established. The primary purpose of this study is to assess the usability of a novel eye-tracking system from the patient's perspective when used in a clinical settings. A secondary purpose is to determine if quantitative data from the eye-tracker correlate with the findings of the traditional clinical neurological examination and to explore whether eye-tracking can provide additional, complementary information not typically captured by standard clinical assessment. To achieve these aims, the study will assess several outcome measures. The primary outcome measure is the Usability of the Eye-Tracking System, which will be measured using the System Usability Scale (SUS). Beyond the primary objectives, this study will investigate two secondary objectives. The first involves assessing the relationship between quantitative eye-tracking parameters and clinical ocular motor assessment. Specifically, the investigators will analyze objective, numerical data obtained from eye-tracking systems and the clinician's subjectively graded assessment of ocular movements derived from the standard neurological examination. The second is the exploratory analysis of novel eye-tracking biomarkers. This involves quantifying and analyzing eye-tracking parameters not typically assessed during a routine NE. For example, the dynamics of the pupillary light reflex or the frequency of microsaccades. The aim is to identify potential digital biomarkers that could provide additional objective insights into ocular motor function and neurological status.

Первичные конечные точки

  • System Usability Scale (SUS) [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
Вторичные конечные точки (12)
  • Vestibulo-ocular reflex (VOR) [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Vestibulo-ocular reflex suppression (VORS) [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Saccades velocity [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Glabella reflex [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Pupillary reflex [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Pupil size at rest [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Nystagmus at rest, slow phase [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Skew deviation [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Smooth pursuit (SP) number of saccades [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Smooth pursuit (SP) saccade amplitude [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Smooth pursuit (SP) slow phase velocity [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]
  • Nystagmus at rest, quick phase [Срок оценки: Baseline (single session, approx. 2-3 hour per participant)]

Критерии участия

Критерии включения

  • ≥ 18 years of age.
  • Diagnosed or treated for a neurological disease.
  • Hospitalized or outpatient of the Department of Neurology, UKSH Campus Kiel.
  • Ability of the person to understand oral study information and study information sheet, and willingness to provide a signed and dated informed consent form.

Критерии исключения

  • Being under legal guardianship
  • Impaired decision-making capacity, or temporal or spatial disorientation which may be revealed within ordinary conversation or by a confirmed diagnosis of dementia. In case of doubt, the Montreal Cognitive Assessment (MoCA, pass cutoff score > 18 16) will be administered.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Германия · 1 центр
  • Department of Neurology — Kiel

Идентификаторы

NCT: NCT07141719 · D 481/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗