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

NCT05106465 | Completed FDA Device

• 1 other identifier: 888MS008
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (MS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

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

  Up to 1 year

• 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

Study Arms (1)

Konectom

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.

Device: Konectom platform

Interventions

Konectom platform DEVICE

Administered as specified in the treatment arm.

Konectom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes participants with a diagnosis of MS who are enrolled in MS PATHS.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Multiple Sclerosis Centre

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 3, 2021
• Study Start: December 15, 2021
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)