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Multiple Sclerosis Prediction and Monitoring of Progression Study

UnknownNA

Sponsor: University Hospital, Ghent

Conditions: Progressive Multiple Sclerosis

Interventions: Bytelfies kit - sensor dot

Countries: Belgium

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Ghent, Oost-Vlaanderen, Belgium