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Multiple Sclerosis Prediction and Monitoring of Progression Study

NCT05685784 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-01-08

No results posted yet for this study

Summary

Multiple sclerosis (MS) is a auto-immune disease that is mostly characterized by acute clinical relapses and/or focal inflammation in the central nervous system (CNS) followed by recovery. Yet, a significant part of the patients also experience a progressive decline in function. This progressive phase usually has an insidious onset causing a delay for diagnosis and adjusted therapies. There are plenty of clinical assessments available to measure walking speed, cognition, sleep,.... . But these assessments are merely a snapshot of the patient 's symptoms. By monitoring these parameters at home, real life data can be provided to capture subclinical signs of progression. The goal of this study is to detect a digital biomarker for progressive MS at an earlier stage next to validating wearables by comparing them to golden standard measurements such a polysomnography or gait analysis in a specialized lab.

Conditions

Interventions

DEVICE

Bytelfies kit - sensor dot

Participants will be asked to undergo a standard of care gait analysis and PSG whilst simultaneously wearing sensor dots. GAIT: sensor dots will be placed in the neck, on the chest and one on both ankles. PSG: sensor dots will be placed on the forehead, chin, chest, abdomen, both legs(tibialis anterior) and an SpO2 device will be placed on the finger middle finger of the non-dominant hand

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • Byteflies

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Guy Laureys, MD, PhD · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685784 on ClinicalTrials.gov