Smart Monitoring Assessing Spasticity-related Health

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Wearing time of smartwatch (daily) [Time frame: 180 days]
• Longitudinal development of activity parameter: step count [Time frame: 180 days]
• Longitudinal development of activity parameter: approximate distance traveled (meter) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 180 days]
• Longitudinal development of activity parameter: sum of all active time (seconds) [Time frame: 180 days]
• Longitudinal development of activity parameter: approximate calories burned Time [Time frame: 180 days]
• Longitudinal development of sleep parameter: time awake (seconds) [Time frame: 180 days]
• Longitudinal development of sleep parameter: number of times user woke up [Time frame: 180 days]

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• Medical Faculty, Heinrich-Heine-University — Düsseldorf

Identifiers

NCT: NCT06937723 · SMASH_1.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗