NCT04281160

Brief Summary

Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that can impact all aspects of nervous system function. Currently clinical assessments as part of the standard of care are performed in the health care providers office during regularly scheduled visits and are semi-quantitative or qualitative in nature. The goal of the BeCare Multiple Sclerosis Assessment App is to allow for patient centered, frequent, and quantitative assessments of neurologic function through a mobile App. The BeCare MS App integrates with all Android and Apple operating systems. The investigator's overall goal is to improve well-being of people with MS through accurate assessment of their neurologic function to be used by themselves as well as their health care providers. The purpose of this Clinical Trial is to validate the App based assessments versus Gold-Standard clinical assessments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

3.5 years

First QC Date

February 20, 2020

Last Update Submit

December 22, 2022

Conditions

Multiple Sclerosis

Keywords

mobile appTUG test25 foot walksix minute walkworking memory testContrast SensitivityCoded Message Cognitive TestFine motor functionDigit Modality test

Outcome Measures

Primary Outcomes (1)

  • Compare the App-based TUG with the clinically derived TUG results

    The Subject is seated in a regular chair with no chair arm-rests. The Subject will stand and then walk to a mark three meters away, turn 180 degrees, walk back to the chair and sit to finish. The test result is recorded as the time from start to finish. For the App-based assessment the Subject will hold their mobile devise in their hand, select the TUG test and then perform the test without external cue. For the traditional TUG, the subject will be instructed to start by a research coordinator who will also start a timer. The research coordinator will stop the timer when the Subject has seated. Three comparisons will be made: App-based result when the Subject self-initiates versus the traditional result; App-based result when the patient self initiates versus the App-based result when the patient is instructed to start; ands App-based result when the patient is instructed to start versus the traditional result.

    6 months

Secondary Outcomes (9)

  • Fine motor function/rapid finger movements (FMF)

    6 months

  • Upper extremity coordination

    6 months

  • Auditory-Comprehension-Typing (ACT) test

    6 months

  • Timed 25-foot walk

    6 months

  • Coded Message Cognitive Test

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Clinical Metric

Patients and healthy controls were evaluated by expert raters with standard clinical metrics of neurologic function.

Device: BeCare Mobile App

Mobile Activity Metric

Patient performed mobile activity

Device: BeCare Mobile App

Interventions

BeCare Mobile AppDEVICE

The BeCare App is a mobile application that will perform routine assessments of neurological function in individuals with MS and address the most relevant domains that are affected in MS: cognition, afferent visual functioning, motor functioning, fine motor functioning, coordination, gait, and endurance

Clinical MetricMobile Activity Metric

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 60 participants will take part in this study: 40 participants with mild to moderate MS and 20 participants without MS will participate in this study.

You may qualify if:

  • Subjects with multiple sclerosis- male and female patients between the ages of 18 and 65 who have been accurately diagnosed with MS based on the revised MacDonald criteria
  • Subjects must have the ability to provide consent and be willing to participate in the study.
  • Participants- both MS subjects and healthy subjects- must self-report having a smartphone on which they can download the BeCare application

You may not qualify if:

  • Subjects must not have a history of concurrent illnesses that result in physical or cognitive disability such as rheumatoid arthritis, osteoarthritis, and Alzheimer's Disease.
  • Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, self reported
  • Subjects who do not own a smartphone in which they can download the BeCare application will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (3)

  • Berrigan LI, Fisk JD, Walker LA, Wojtowicz M, Rees LM, Freedman MS, Marrie RA. Reliability of regression-based normative data for the oral symbol digit modalities test: an evaluation of demographic influences, construct validity, and impairment classification rates in multiple sclerosis samples. Clin Neuropsychol. 2014;28(2):281-99. doi: 10.1080/13854046.2013.871337. Epub 2014 Jan 20.

    PMID: 24438521BACKGROUND

  • Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.

    PMID: 21387374RESULT

  • Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

    PMID: 26944709RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Larry D Rubin, MPh

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

February 19, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)