Progressive Multiple SclerosisPREMONITIONNCT05685784
Multiple Sclerosis Prediction and Monitoring of Progression Study
A study testing Bytelfies kit - sensor dot in people with Progressive Multiple Sclerosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- Bytelfies kit - sensor dot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, Oost-Vlaanderen, 9000
Liesbeth Van Hijfte, M.Sc., +3293321168, liesbeth.vanhijfte@uzgent.be
Guy Laureys, MD, PhD, guy.laureys@uzgent.be
About this study
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.
Read the 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
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- Bytelfies kit - sensor dot
- Keywords
- wearables
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bytelfies kit - sensor dotDevice
Also called Gait analysis validation, PSG validation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Bytelfies kit - sensor dot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
A clinical evaluation of subjects for possible local reactions at the skin-device contact sites will be performed.
Measured: GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Mar 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, monocentric diagnostic study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Byteflies
- Responsible party
- Sponsor
- Investigators
- Guy Laureys, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685784
- Sponsor's protocol ID
- BC-07811
- Other IDs
- CIV-BE-20-09-034669
- Acronym
- PREMONITION
- Status last verified
- Jan 2024
- First submitted
- 9 Oct 2020
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request, depending on terms
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis Prediction and Monitoring of Progression Study
- ClinicalTrials.gov ID
- NCT05685784
- Acronym / sponsor ID
- PREMONITION / BC-07811
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- wearables
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Byteflies
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, monocentric diagnostic study
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Device: Bytelfies kit - sensor dot* 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 |
| People with MS | Experimental | Device: Bytelfies kit - sensor dot* 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bytelfies kit - sensor dotAlso: Gait analysis validation, PSG validationParticipants 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 | Device | Healthy volunteer, People with MS |
Primary outcome
To validate outpatient gait analysis using sensor dots, with regards to the golden standard
Time frame: 1 single study visit which takes approximately 2 hours
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
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
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
1 secondary outcome
Skin-device contact safety
Time frame: GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No. on request, depending on terms
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Laureys, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bytelfies kit - sensor dot in people with Progressive Multiple Sclerosis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liesbeth Van Hijfte, Master (+3293321168, liesbeth.vanhijfte@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate outpatient gait analysis using sensor dots, with regards to the golden standard (time frame: 1 single study visit which takes approximately 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.