NCT06937723

Smart Monitoring Assessing Spasticity-related Health

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Device: Smartwatch (Withings Scanwatch)	All-day monitoring of patients via smartwatch

Timeline

• Start date: 2023-10-19
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: Germany