Multiple Sclerosis Prediction and Monitoring of Progression Study (PREMONITION)
Progressive Multiple Sclerosis
About this trial
This is an interventional diagnostic trial for Progressive Multiple Sclerosis focused on measuring wearables
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.
Sites / Locations
- University Hospital GhentRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Healthy volunteer
People with MS
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