NCT03369171

Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance. With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability. In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.

Detailed description

Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance. With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability. In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)	MYO armband is a commercialized, gesture control device containing "Height Medical Grade Stainless Steel EMG sensors", and an inertial measurement unit (IMU) consisting of a three-axis gyroscope and a, three-axis accelerometer, three-axis magnetometer. MY0 motion data (EMG and IMU) will be recorded during standard motor/neurological evaluation. The clinical assessment will include standard motor neurological evaluation : EDSS and FS, walking status, foot tapping test, Heel-knee test, finger tapping test, Finger to nose test, Romberg test, timed 25 foot walk test, nine holes peg test. This clinical assessment will be done at the inclusion visit (V1) and at the follow-up visit at one year (V2).

Timeline

• Start date: 2018-01-23
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2017-12-11
• Last updated: 2020-05-19

Locations

1 site across 1 country: France