Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)
Intervention type(s): Device
Intervention description(s): 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).
Other intervention name(s): MYO, Gesture control armband
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other