A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and Magnetic Resonance Imaging (MRI) Measures of Brain Tissue Damage

NCT ID: NCT05106465

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-04-03

Brief Summary

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The purpose of the study is to explore association patterns between digital outcome assessments from Konectom and MRI measures of brain tissue damage.

Detailed Description

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Conditions

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Multiple Sclerosis (MS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Konectom

Participants with a diagnosis of MS or clinically isolated syndrome who are enrolled in Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) and who own a smartphone model compatible with the Konectom platform will be enrolled.

Konectom platform

Intervention Type DEVICE

Administered as specified in the treatment arm.

Interventions

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Konectom platform

Administered as specified in the treatment arm.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Should be enrolled in multiple sclerosis partners advancing technology and health solutions (MS PATHS).
* Participant (or participant's legal representative) has the ability to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
* Should have literacy of written language in which the software and Instructions for use are displayed (User Interface \[UI\], Instructions).

Exclusion Criteria

* Unable or unwilling to provide informed consent.
* Inability to use a smartphone as per physician's opinion.
* Not owning a Konectom-compatible smartphone.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Multiple Sclerosis Centre

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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888MS008

Identifier Type: -

Identifier Source: org_study_id

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