An interventional study of Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) in Multiple Sclerosis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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).
Also known as: MYO, Gesture control armband
Discrimination of walking disorder status
Normal or Abnormal walking status of MS patients will be determined at baseline based on clinical judgement and compared to EMG data from calf muscle of the more affected limb combined with Inertial Motion Unit (IMU).
Time frame: Day 0
Foot tapping test
\[Foot tapping test is used to assess rapid alternating movement of the lower extremity and coordination\]. Each lower extremity is assessed separately (by neurologist) while MYO is placed over calf muscle. Foot tapping test result based on clinical judgment is compared to MYO motion data.
Time frame: day 0
Finger tapping test
\[Finger tapping test is used to assess rapid alternating movement of the upper extremity and coordination\]. Each extremity is assessed separately (by neurologist) while MYO is placed over forearm muscle. Finger tapping test result based on clinical judgment is compared to MYO motion data.
Time frame: day 0
Heel-knee test
: \[Heel knee test is used to assess coordination of lower extremities and to detect cerebellum dysfunction\]. Each extremity is tested separately (by neurologist) while MYO is placed over calf muscle. Heel-knee test result based on clinical judgment is compared to MYO motion data
Time frame: day 0
Romberg test
The Romberg test is used to assess balance. The test is performed while the patient is wearing MYO on the calf of the most affected leg
Time frame: day 0
Finger to nose test
\[Finger to nose test is used to assess coordination of upper extremity movement\]. Each extremity is assessed separately (by neurologist) while MYO is placed over forearm muscle. Finger to nose test result based on clinical judgment is compared to MYO motion data
Time frame: day 0
Timed 25 foot walk test result
Timed 25 foot walk (T25FW) is used to measure walking function based on time. T25FW is a quantitative mobility and leg function performance test. Patient is asked to walk 25 feet with MYO device placed over calf muscle of the most affected leg
Time frame: day 0
Nine holes peg test
The nine holes peg test (9-HPT) is used to measure fine manual dexterity. 9-HPT measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. Each side is tested separately with MYO placed over forearm muscle. Ability of MYO sensor to detect upper dysfunction is evaluated.
Time frame: day 0
Expanded disability status scores (EDSS)
EDSS is a 20-step ordinal scale of disease severity ranging from to 10 in 0.5 increments (when reaching EDSS 1), with higher scores indicating more disability. Scoring is based on assessment by a neurologist of clinical deficit (rate from 0 to 5 or 6) in 8 functional systems (FS) combined with ambulation ability/mobility
Time frame: Day 0 and at one year
Patient-reported disability using self-report questionnaire
The questionnaire comprises 17 questions related to MS. To study the relationship between MYO motion data and patient-perceived disability
Time frame: Day 0 and at one year
Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale
: MSWS-12 is a 12-item patient rate measure of the impact of MS on the individual's walking ability during the past 2 weeks. Each item is rate from 1 (no difficulty) to 5 (extreme difficulty) then summed (ranging from 12 to 60, with higher score reflecting a greater impact of MS on walking). To study the relationship between MYO motion data and patient-perceived mobility.
Time frame: Day 0 and at one year
12-item version of World Health Organization Disability Assessment Schedule (WHODAS 2.0)
The short version of WHODAS 2.0 comprises 12 questions related to difficulties experienced in six domains (mobility, self-care, life activities, understanding and communicating interpersonal interactions, and participation in society) during the previous 30 days. Each item is rated from 1 (no problem) to 5(extreme). The scores from each item are summed to generate a total score ranging from 12 to 60, with higher score reflecting higher levels of disability. To study the relationship between MYO motion data and quality of life (related to disability)
Time frame: Day 0 and at one year
Disability as measured with EDSS score
To study the relationship between MYO motion data and physician-scored rated disability
Time frame: Day 0 and at one year
Disability as measured with Functional systems score (FS)
To study the relationship between MYO motion data and physician-scored rated disability
Time frame: Day 0 and at one year
Dysfunction assessed by walking disorder status
Dysfunction assessed by clinical exam of walking disorder status is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by foot tapping test
Dysfunction assessed by clinical exam of foot tapping test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by finger tapping test
Dysfunction assessed by clinical exam of finger tapping test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by heel-knee test
Dysfunction assessed by clinical exam of heel-knee test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by Romberg test
Dysfunction assessed by clinical exam of Romberg test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by finger to nose test
Dysfunction assessed by clinical exam of finger to nose test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by timed 25 foot walk test result
Dysfunction assessed by clinical exam of timed 25 foot walk test is compared to MYO motion data.
Time frame: Day 0 and at one year
Dysfunction assessed by nine holes peg test
Dysfunction assessed by clinical exam of nine holes peg test is compared to MYO motion data.
Time frame: Day 0 and at one year
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Nantes University Hospital