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

Completed

• Conditions: Multiple Sclerosis (MS)
• Interventions: Device: Konectom platform

• Registration Number: NCT05106465
• Lead Sponsor: Biogen

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-03
• Study Start: 2021-12-15
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Konectom	Konectom platform	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.

Primary Outcome Measures

Name	Time	Method
Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage	Up to 1 year	Konectom tests include cognitive processing speed test (CPST), pinching test, drawing test, static balance test (SBT)/u-turn test (UTT) and 6-minute walking test (6MWT).

Secondary Outcome Measures

Name	Time	Method
Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data	Up to 1 year	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.
Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data	Up to 1 year	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.
Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Fluid-attenuated Inversion Recovery (FLAIR) Hyperintense MS Lesions Using 3D-T1 and 3D FLAIR Data	Up to 1 year	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.
Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data	Up to 1 year	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.

Trial Locations

Locations (1)

Multiple Sclerosis Centre; 🇩🇪 Dresden, Germany