Multiple Sclerosis Prediction and Monitoring of Progression Study
Multiple Sclerosis Prediction and Monitoring of Progression Study
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Bytelfies kit - sensor dot
What it measured
Main measures
To validate outpatient gait analysis using sensor dots, with regards to the golden standard
1 single study visit which takes approximately 2 hours
Walking and mobilityTo validate outpatient polysomnography using sensor dots, with regards to the golden standard
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 dur
Nerve conduction testsMood and sleep
Other measures (1)
Skin-device contact safety
GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days
Safety
Who could take part
Relapsing and progressive · 18 to 60
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2022
Main results due
Sept 2024
Finished
Sept 2024