Progressive Multiple Sclerosis Clinical Trial
— PREMONITIONOfficial title:
Multiple Sclerosis Prediction and Monitoring of Progression 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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Byteflies, University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
1 single study visit which takes approximately 2 hours | |
Primary | 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 |
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 | Skin-device contact safety | A clinical evaluation of subjects for possible local reactions at the skin-device contact sites will be performed. | GAIT: 2 hours; Sleep (healthy volunteers): 15 hours; Sleep (PwMS): 3 days |
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