Multiple Sclerosis Prediction and Monitoring of Progression Study

NCT05685784 | Unknown DMC

• 2 other identifiers: BC-07811CIV-BE-20-09-034669
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Progressive Multiple Sclerosis

Keywords

wearables

Outcome Measures

Primary Outcomes (2)

• To validate outpatient gait analysis using sensor dots, with regards to the golden standard

  Participants (healthy volunteers and MS patients) will perform a gait analysis on the Gait Real-time Analysis Interactive Lab (GRAIL), which is considered to be the golden standard, whilst simultaneously wearing the byteflies sensor dots. By comparing data from the GRAIL (golden standard) with the data from the sensor dots, which uses gyroscopic and accelerometric data, we aim to be able to validate the following gait parameters for outpatient use: * Stride length * Stride time * Stance (%) * Total double support (%) * Single support (%) * Walking speed * Cadence

  1 single study visit which takes approximately 2 hours

• To validate outpatient polysomnography using sensor dots, with regards to the golden standard

  Participants (non-MS and MS patients)with an indication for polysomnography(PSG) will undergo a standard PSG with a simultaneous Byteflies sensor dot registration for comparising. Patients with MS will undergo an additional outpatient sleep analysis with the byteflieskit during 2 consecutive nights. The following parameters will monitored by the byteflies sensor dots. * Electrooculography (EOG): for eye movements. * Electroencephalografphy (EEG): EEG signals to define the sleeping stages * Oxygenation * Chest wall expansion: calculated with accelerometric and gyroscopic monitoring * Electrocardiography(ECG): ECG signals to measure heart rate and heart rate variability * Leg movement: calculated with accelerometric and gyroscopic monitoring

  Healthy participants: 1 study visit which encompasses an overnight stay in the hospital. Duration: about 15 hours. PwMS: 1 overnight stay, followed by outpatient sleep analysis for 2 nights. Total duration: 3 days

Secondary Outcomes (1)

• Skin-device contact safety

  GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days

Study Arms (2)

Healthy volunteer

EXPERIMENTAL

* 20 Healthy volunteers required for gait measurement: Standard gait analysis whilst simultaneously wearing the investigational sensor dots * 15 Non-MS patients with an indication for polysomnography (PSG): Standard PSG whilst simultaneously wearing the investigational sensor dots

Device: Bytelfies kit - sensor dot

People with MS

EXPERIMENTAL

* 20 patients with MS required for gait measurement: Standard gait analysis whilst simultaneously wearing the investigational sensor dots * 15 MS patients with an indication for polysomnography (PSG): Standard PSG whilst simultaneously wearing the investigational sensor dots

Device: Bytelfies kit - sensor dot

Interventions

Bytelfies kit - sensor dot DEVICE

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

Also known as: Gait analysis validation, PSG validation

Healthy volunteer; People with MS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Relapsing Remitting (RR) or Primary Progressive (PPMS) MS as defined by 2017 Mc Donald criteria, or Secondary Progressive (SPMS) according to Lorscheider criteria AND having an EDSS ≤ 6.5
• Healthy control
• Non-MS Patient with an indication for polysomnography
• Age 18-60 years inclusive

You may not qualify if:

• Patients who were prescribed 4-aminopyridin during the last 30 days.
• Patients with severe cardiac, pneumological, neurological, hematological, immunological, infectious, rheumatoid, endocrinological, gastro-intestinal, urological comorbidity that may interfere with outcome measures as determined by the investigators.
• Confirmed clinical relapses or new lesions on MRI during the last six months
• Known allergy to electrodes used as part of the study protocol
• Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Byteflies: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Laureys, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liesbeth Van Hijfte, Master

CONTACT

+3293321168; liesbeth.vanhijfte@uzgent.be

Cathérine Dekeyser, MD

CONTACT

+32 9 33 25609; catherine.dekeyser@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, monocentric diagnostic study

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: January 17, 2023
• Study Start: March 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)