Smart Monitoring Assessing Spasticity-related Health

Официальное название

Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables

Обзор

This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.

Подробное описание

The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.

Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.

The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.

Вмешательства

• Другое Device: Smartwatch (Withings Scanwatch)
  All-day monitoring of patients via smartwatch

Первичные конечные точки

• Wearing time of smartwatch (daily) [Срок оценки: 180 days]
• Longitudinal development of activity parameter: step count [Срок оценки: 180 days]
• Longitudinal development of activity parameter: approximate distance traveled (meter) [Срок оценки: 180 days]
• Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television [Срок оценки: 180 days]
• Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton [Срок оценки: 180 days]
• Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles) [Срок оценки: 180 days]
• Longitudinal development of activity parameter: sum of all active time (seconds) [Срок оценки: 180 days]
• Longitudinal development of activity parameter: approximate calories burned Time [Срок оценки: 180 days]
• Longitudinal development of sleep parameter: time awake (seconds) [Срок оценки: 180 days]
• Longitudinal development of sleep parameter: number of times user woke up [Срок оценки: 180 days]

Вторичные конечные точки (11)

• WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• The Expanded Disability Status Scale (EDSS) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• Smartwatch Questionnaire [Срок оценки: 6 months (V3)]
• End of Dose Questionnaire (EOD) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• McCorkle and Young Symptom Distress Scale [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• The Multiple Sclerosis Impact Scale 29 (MSIS-29) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• The Numeric Rating Scale (NRS) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• The Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• The Edmonton Symptom Assessment Scale (ESAS) [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• Sleep-Questionnaire [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]
• EQ-5D-5L [Срок оценки: Screening + Baseline (V1), 3 months (V2), 6 months (V3)]

Критерии участия

Критерии включения

Patients must meet all the following criteria to be eligible to participate in the study:

• ≥ 18 years of age
• Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
• Presence of spasticity that requires medical treatment from a medical point of view
• own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
• Able to operate a smartphone

Критерии исключения

• Missing informed consent
• Lack of declaration of consent
• Unwillingness or inability to use the smartphone app
• Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Medical Faculty, Heinrich-Heine-University — Düsseldorf

Идентификаторы

NCT: NCT06937723 · SMASH_1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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