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Идёт набор NCT06526364

Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)

Наблюдательное Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive

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: All participants will be asked to provide data and samples for collection and analysis..
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Clinnova-MS: a Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (Switzerland)

Обзор

This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.

Подробное описание

Multiple Sclerosis (MS) is a chronic disease of the central nervous system that causes a range of neurological symptoms, such as cognitive issues, fatigue, vision problems, and muscle weakness. There are two main forms: relapsing-remitting MS (RRMS) with episodes of symptoms that improve on their own, and primary progressive MS (PPMS) with chronically worsening symptoms. Many RRMS patients eventually develop secondary progressive MS (SPMS), where disability worsens without remissions. What causes MS remains unknown, but it is thought to involve genetic and environmental factors. Diagnosis and monitoring typically involve patient history, neurologic examination in combination with magnetic resonance imaging (MRI), and other tests, but these methods are costly and time-consuming. Efforts are made to develop digital tools for continuous patients monitoring.

This study is part of the Clinnova programme, aiming to collect standardized and high-quality digital health data. Clinnova-MS is a prospective cohort study including patients with early MS or those transitioning to progressive MS. Up to 100 patients, recruited from the ongoing Swiss MS cohort study, are enrolled in Basel, Switzerland. An equivalent number of patients are enrolled in other Clinnova centers, reaching at least 800 patients in total. The study aims to provide a structured and standardized highly granular dataset, allowing for the phenotyping of patients with similar patterns and disease courses. It also facilitates transnational data linkage the analysis of complex and heterogeneous data from MS patients.

The primary objective of the study is to derive a set of biomarkers that will better characterize the clinical phenotype and progression of the disease, as well as the functional impairment of MS patients at different stages. These biomarkers will aid clinicians in making informed treatment decisions for patients with early MS or those transitioning to progressive MS.

Вмешательства

  • Другое All participants will be asked to provide data and samples for collection and analysis.
    During the first year, data related to demographics, lifestyle, clinical examinations will be collected at baseline, at 6 months (optional) and at 12 months. PROs, cognitive and motor assessments will be performed using the Healios+Me smartphone app. Additionally, participants will be asked to provide biological samples (i.e., blood, cerebrospinal fluid and stool, saliva and hair) and imaging data (if performed as per standard of care). One unscheduled visit may be performed in case the particip

Первичные конечные точки

  • Set of biomarkers [Срок оценки: 2029]
Вторичные конечные точки (12)
  • Expanded Disability Status Scale (EDSS) [Срок оценки: Baseline and once a year for up to 5 years]
  • 9-Hole Peg Test (9-HPT) [Срок оценки: Baseline and once a year for up to 5 years]
  • Timed 25-Foot Walk (T25FW) [Срок оценки: Baseline and once a year for up to 5 years]
  • Stroop Test (Victoria Version) [Срок оценки: Baseline and once a year for up to 5 years]
  • Symbol Digit Modalities Test (SDMT) [Срок оценки: Baseline and once a year for up to 5 years]
  • Trail Making Test A&B (TMT A&B) [Срок оценки: Baseline and once a year for up to 5 years]
  • Multiple Sclerosis Inventory of Cognition (MUSIC) [Срок оценки: Baseline and once a year for up to 5 years]
  • Digit span backwards (DSB) [Срок оценки: Baseline and once a year for up to 5 years]
  • Rey-Osterrieth Complex Figure Test (ROCF) [Срок оценки: Baseline and once a year for up to 5 years]
  • Verbal Learn and Memory Test (VLMT) [Срок оценки: Baseline and once a year for up to 5 years]
  • Near vision acuity test [Срок оценки: Baseline and once a year for up to 5 years]
  • Contrast vision test (Pelli-Robson low-contrast chart) [Срок оценки: Baseline and once a year for up to 5 years]

Критерии участия

Критерии включения

  • Age ≥18
  • Participants are willing and able to comply with the protocol, including undergoing data and samples collection as well as study visits and examinations.
  • Signed informed consent form
  • In possession of a Healios+Me app compatible smartphone (iOS/Android)
  • Corrected close visual acuity of ≥0.5
  • Hand motor skills sufficient for using a smartphone
  • Ability to follow the study procedures
  • Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (clinically isolated syndrome, RRMS, SPMS, PPMS) AND early disease stages (< 3 years) OR transitioning phase to progressive disease as evaluated based on Expanded Disability Status Scale (EDSS).
  • Enrolled in the SMSC at University Hospital Basel

There are no specific exclusion criteria.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) — Basel

Идентификаторы

NCT: NCT06526364 · 2023-01640; ko23Granziera

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗