Multiple Sclerosis Prediction and Monitoring of Progression Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Belgium
University Hospital Ghent
RECRUITING
Ghent
Contact Information
Primary
Liesbeth Van Hijfte, Master
liesbeth.vanhijfte@uzgent.be
+3293321168
Backup
Cathérine Dekeyser, MD
catherine.dekeyser@uzgent.be
+32 9 33 25609
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 70
Treatments
Experimental: Healthy volunteer
* 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
Experimental: People with MS
* 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
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent, Byteflies
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov