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

Biogen

Status: Completed

Conditions: Multiple Sclerosis (MS)

Treatments: Device: Konectom platform

Study type: Observational

Funder types: Industry

Identifiers

NCT05106465

888MS008

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

200 participants in 1 patient group

Konectom

Description:

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.

Treatment:

Device: Konectom platform