Monitoring spasticity in multiple sclerosis using smart technology
Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables
This study is testing if using smartwatches to track symptoms can help people with multiple sclerosis better understand and manage their spasticity over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT06937723 on ClinicalTrials.gov |
What this trial studies
This observational study investigates spasticity in patients with multiple sclerosis (MS) through multimodal monitoring techniques. By integrating digital biomarkers from smartwatches with clinical assessments, the study aims to evaluate the effectiveness of these digital measurements in monitoring everyday limitations caused by spasticity. Approximately 50 patients will be followed over three visits, every 12 weeks, to gather comprehensive data on their symptoms and treatment responses. The goal is to enhance understanding of spasticity and improve treatment monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of multiple sclerosis and moderate to severe spasticity requiring medical treatment.
Not a fit: Patients with significant comorbidities affecting their ability to understand or complete the study may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to better management of spasticity in MS patients through more accurate monitoring and tailored treatments.
How similar studies have performed: While the use of digital health tools in monitoring conditions like MS is emerging, this specific multimodal approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- Medical Faculty, Heinrich-Heine-University — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Marc Pawlitzki, PD Dr. med.
- Email: neuro-trials@med.uni-duesseldorf.de
- Phone: 0049 21181-17889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.