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

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106465
• Other study ID #: 888MS008
• Status: Completed
• Start date: December 15, 2021
• Est. completion date: April 3, 2024

Study information

• Verified date: May 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)

Intervention

Device:
• Konectom platform
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Germany	Multiple Sclerosis Centre	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage	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).	Up to 1 year
Secondary	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	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.	Up to 1 year
Secondary	Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.	Up to 1 year
Secondary	Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.	Up to 1 year
Secondary	Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data	Konectom tests include CPST, pinching test, drawing test, SBT/UTT and 6MWT.	Up to 1 year