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

Konect-MF: A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and MRI Measures of Brain Tissue Damage

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05106465

Enrollment

200

Registered

2021-11-03

Start date

2021-12-15

Completion date

2024-04-03

Last updated

2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

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.

Interventions

DEVICEKonectom platform

Administered as specified in the treatment arm.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026