Smart Monitoring Assessing Spasticity-related Health (SMASH)

Heinrich-Heine University, Duesseldorf

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Other: Device: Smartwatch (Withings Scanwatch)

Study type

Observational

Funder types

Other

Identifiers

NCT06937723

SMASH_1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.