DreaMS - Digital Biomarkers for Multiple Sclerosis

NCT04413032 | Completed DMC

• 1 other identifier: DreaMS_2020F
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques. In this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Test Reliability of digital biomarkers measured by Intra Class Correlation

  Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times

  6 weeks

• Test Reliability of digital biomarkers measured by Coefficient of variation

  Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times

  6 weeks

• Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale

  Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.

  6 weeks

Study Arms (2)

Patients with MS

EXPERIMENTAL

30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.

Device: DreaMS

Healthy Volunteers

EXPERIMENTAL

30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.

Device: DreaMS

Interventions

DreaMS DEVICE

The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.

Healthy Volunteers; Patients with MS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS)
• EDSS ≤ 6.5
• In possession of a smart phone

You may not qualify if:

• Age \<18 and \> 70
• EDSS \> 6.5
• Other clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• Women who are pregnant or breast feeding
• Not in possession of a smart phone
• Healthy Volunteers
• Age 18-70
• In possession of a smart phone
• Age \<18 and \> 70
• Diagnosis of MS
• Clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Sponsors & Collaborators

• Research Center for Clinical Neuroimmunology and Neuroscience Basel: lead

Study Sites (1)

RC2NB

Basel, 4031, Switzerland

Location

Related Publications (2)

• Pless S, Woelfle T, Naegelin Y, Lorscheider J, Wiencierz A, Reyes O, Calabrese P, Kappos L. Assessment of cognitive performance in multiple sclerosis using smartphone-based training games: a feasibility study. J Neurol. 2023 Jul;270(7):3451-3463. doi: 10.1007/s00415-023-11671-9. Epub 2023 Mar 23.

  PMID: 36952010 DERIVED

• Woelfle T, Pless S, Reyes O, Wiencierz A, Feinstein A, Calabrese P, Gugleta K, Kappos L, Lorscheider J, Naegelin Y. Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study. J Neurol. 2023 Jan;270(1):262-271. doi: 10.1007/s00415-022-11306-5. Epub 2022 Aug 30.

  PMID: 36042020 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos, MD

  University Hospital Basel and RC2NB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A group of patients with Multiple Sclerosis and a group of healthy volunteers will use the dreaMS App over the period of 6 weeks.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 2, 2020
• Study Start: October 5, 2020
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

CH (1)