Smart Monitoring Assessing Spasticity-related Health

NCT ID: NCT06937723

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MS patients

Patients with Multiple Sclerosis

Device: Smartwatch (Withings Scanwatch)

Intervention Type: OTHER

All-day monitoring of patients via smartwatch

Interventions

Device: Smartwatch (Withings Scanwatch)

All-day monitoring of patients via smartwatch

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Marc Günter Pawlitzki

Study coordinator / PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marc Pawlitzki, PD Dr. med.

Role: CONTACT

neuro-trials@med.uni-duesseldorf.de

0049 21181-17889

Facility Contacts

Marc Pawlitzki, PD Dr. med.

Role: primary

neuro-trials@med.uni-duesseldorf.de

0049 21181-17889

Other Identifiers

SMASH_1.0

Identifier Type: -

Identifier Source: org_study_id