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Набор скоро начнётся NCT07201610

Non-invasive Diagnosis of Parkinson's Disease

— Наблюдательное Parkinsons Disease (PD)

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: Parkinsons Disease (PD). Базовые параметры: 60 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
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

Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis

Обзор

This study will investigate new, non-invasive methods to help diagnose Parkinson's disease. Researchers will use advanced eye imaging (hyperspectral retinal photography and OCT), computerized memory and thinking tests, and voice analysis to identify patterns linked to Parkinson's. The goal is to improve early and accurate diagnosis of Parkinson's disease without the need for spinal taps or invasive tests.

Подробное описание

This study aims to improve how Parkinson's disease is diagnosed by testing new, non-invasive techniques that do not require spinal taps or other invasive procedures. Researchers are investigating whether changes in the eye's retina, detected with hyperspectral imaging and optical coherence tomography (OCT), can help pinpoint Parkinson's disease. These methods use special photographs and scans, similar to those performed at an eye clinic or optometrist, to analyze patterns linked to nerve cells and blood vessels in the retina.

Additionally, participants will take computerized tests to measure memory, attention, and thinking skills. Since Parkinson's disease can also affect speech, the study will analyze voice recordings for specific changes that are common in the disease, such as reduced volume and strength. By combining information from eye images, cognitive tests, and voice analysis, the project hopes to develop a faster and more accurate way to diagnose Parkinson's disease at an earlier stage.

The study is open to both people with Parkinson's disease and healthy volunteers, and the new diagnostic tools being tested could make future diagnosis simpler, more comfortable, and accessible to a wider population

Первичные конечные точки

  • Performance of combined model, retinal, voice and cognitive data [Срок оценки: Through study completion, an average of 6 months]
  • Performance retinal biomarkers [Срок оценки: Through study completion, an average of 6 months]
Вторичные конечные точки (2)
  • Diagnostic performance of each modality on its own. [Срок оценки: Through study completion, an average of 6 months]
  • Correlational analyses [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Inclusion criteria for Parkinson's group:

  • Age 60-80 years
  • Diagnosis of idiopathic Parkinson's disease
  • Ability to understand spoken and written Swedish
  • Ability to personally provide consent to participate in the study
  • At least one healthy eye for retinal photography

Inclusion criteria for control group:

  • Age 60-80 years
  • Ability to understand spoken and written Swedish
  • Ability to personally provide consent to participate in the study
  • At least one healthy eye for retinal photography
  • Healthy as defined below

Критерии исключения

  • At least one eye must not have retinal disease, glaucoma, or vascular eye disease (such as embolism)
  • Angle-closure glaucoma or other contraindication to mydriatic drops
  • Low functional ability that makes participation in examinations impossible
  • Diagnosed dementia
  • Specifically for the control group: Not healthy according to the definition below

Definition of healthy:

  • No diagnosed or suspected Parkinson's disease
  • No diagnosed or suspected cognitive disease
  • No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression)
  • Cognitive testing with MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07201610 · ps_hsi

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗