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Completed

NCT Number: NCT05106465

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

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

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Sclerosis Centre

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Konectom platform

Device

Administered as specified in the treatment arm.

Primary outcomes

  1. Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage

    Time frame: 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 outcomes

  1. 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

    Time frame: Up to 1 year

    Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.

  2. Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data

    Time frame: Up to 1 year

    Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.

  3. Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data

    Time frame: Up to 1 year

    Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.

  4. Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data

    Time frame: Up to 1 year

    Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2021
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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