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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged between 18 to 64 years inclusive (Patients over 64 years will not be enrolled to avoid possible effect of aging on the voluntary movement assessed);
• Confirmed diagnosis of MS according to the revised McDonald criteria (including primary progressive, secondary progressive and relapsing-remitting MS) with brain lesions consistent with MS if data available;
• No history of relapse in the previous 5 weeks.
• Must be able or think they are able to attempt both finger and foot tapping tests, F2NT, 9HPT and be ambulatory with or without assistance.

Exclusion Criteria:

• Pregnant women
• Minors
• Adults under guardianship
• Adults over 64 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients with MYO armband

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).; Other Names: MYO, Gesture control armband

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	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	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.	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	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	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.	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)	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	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	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.	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.	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.	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.	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.	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.	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.	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.	Day 0 and at one year

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: David Laplaud, PU-PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC16_0391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No