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Multiple Sclerosis Prediction and Monitoring of Progression Study (PREMONITION)

Primary Purpose

Progressive Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bytelfies kit - sensor dot
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Progressive Multiple Sclerosis focused on measuring wearables

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • University Hospital GhentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy volunteer

People with MS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Skin-device contact safety
A clinical evaluation of subjects for possible local reactions at the skin-device contact sites will be performed.

Full Information

First Posted
October 9, 2020
Last Updated
January 5, 2023
Sponsor
University Hospital, Ghent
Collaborators
University Ghent, Byteflies
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1. Study Identification

Unique Protocol Identification Number
NCT05685784
Brief Title
Multiple Sclerosis Prediction and Monitoring of Progression Study
Acronym
PREMONITION
Official Title
Multiple Sclerosis Prediction and Monitoring of Progression Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 12, 2025 (Anticipated)
Study Completion Date
December 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent, Byteflies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Background: Multiple sclerosis (MS) is the most common cause of non-traumatic neurological disability in young adults leading to an important personal and socio-economic burden. From a pathophysiological point of view MS is considered to be an autoimmune disease in which the immune system mistakenly attacks the central nervous system (CNS). MS is usually devided into three clinical phases. Most people with MS experience sudden relapses followed by a remitting periode (RRMS). Fot this type of MS, the therapeutic landscape has evolved extensively over the last decade. Unfortunately, a significant part of the patients still experience progressive decline in function despite not experiencing discrete clinical relapses. The progressive MS phenotype can be divided in two subtypes known as SPMS and primary progressive MS (PPMS) dependent on preceding RRMS or not. A variety of clinical measures has enabled us to compose a valid follow-up of the disease course, yet they do not evaluate outpatient or long-term monitoring and they also lack sensitivity for early detection of disability progression. Up-to-date, there is no clear consensus on how to diagnose SPMS and it remains difficult to define when a patient enters the progressive phase as the diagnosis is usually made retrospectively. Implementing digital biomarkers would potentially provide us with a more realistic and more sensitive view of the progressive evolution in different spheres of functioning. This also counts for autonomic dysfunction and sleeping disorders, where no standardized monitoring is available for MS. Using wearables to capture the digital biomarkers could fill the gap of knowledge in evaluating, monitoring and predicting disability progression in MS. to this day there is no precise biomarker or composite tool that can differentiate the MS phenotypes or help us initiate/adjust therapy earlier on in progression. Introducing wearable's that could collect basic clinical parameters on a day-to-day basis would potentially give researchers a more realistic and more sensitive insight of the general course of the disease. Rationale: Evolution in machine learning enables unbiased detection of biomarkers encoded in different biosignal modalities. The ability to track MS disease-related physiological and behavioral signals over longer periods of time on an outpatient basis serves the unmet need of early diagnosis and adequate monitoring of (relapse independent) disease progression. This has major clinical implications since biomonitoring could be a critical tool for MS care practitioners in patient-centered multidisciplinary care. Study design: This is an open-label, monocentric diagnostic study where the investigators will test the feasibility and validity (as compared to golden standard measures) of wearables, provided by Byteflies, in adequate extended outpatient evaluation and monitoring of PwMS. The investigators will further evaluate how these biosignals correlate with conventional outcome measures at their primary visit to evaluate the prognostic potential of wearable monitoring

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis
Keywords
wearables

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, monocentric diagnostic study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteer
Arm Type
Experimental
Arm Description
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
Arm Title
People with MS
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bytelfies kit - sensor dot
Other Intervention Name(s)
Gait analysis validation, PSG validation
Intervention Description
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
Primary Outcome Measure Information:
Title
To validate outpatient gait analysis using sensor dots, with regards to the golden standard
Description
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
Time Frame
1 single study visit which takes approximately 2 hours
Title
To validate outpatient polysomnography using sensor dots, with regards to the golden standard
Description
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
Time Frame
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 Outcome Measure Information:
Title
Skin-device contact safety
Description
A clinical evaluation of subjects for possible local reactions at the skin-device contact sites will be performed.
Time Frame
GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbeth Van Hijfte, Master
Phone
+3293321168
Email
liesbeth.vanhijfte@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Cathérine Dekeyser, MD
Phone
+32 9 33 25609
Email
catherine.dekeyser@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Laureys, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Van Hijfte, M.Sc.
Phone
+3293321168
Email
liesbeth.vanhijfte@uzgent.be
First Name & Middle Initial & Last Name & Degree
Guy Laureys, MD, PhD
Email
guy.laureys@uzgent.be

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
on request, depending on terms

Learn more about this trial

Multiple Sclerosis Prediction and Monitoring of Progression Study

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