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Completed

NCT Number: NCT03369171

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)

Device

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

Primary outcomes

  1. Discrimination of walking disorder status

    Time frame: Day 0

    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).

Secondary outcomes

  1. Foot tapping test

    Time frame: day 0

    [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.

  2. Finger tapping test

    Time frame: day 0

    [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.

  3. Heel-knee test

    Time frame: day 0

    : [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

  4. Romberg test

    Time frame: day 0

    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

  5. Finger to nose test

    Time frame: day 0

    [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

  6. Timed 25 foot walk test result

    Time frame: day 0

    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

  7. Nine holes peg test

    Time frame: day 0

    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.

  8. Expanded disability status scores (EDSS)

    Time frame: Day 0 and at one year

    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

  9. Patient-reported disability using self-report questionnaire

    Time frame: Day 0 and at one year

    The questionnaire comprises 17 questions related to MS. To study the relationship between MYO motion data and patient-perceived disability

  10. Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale

    Time frame: Day 0 and at one year

    : 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.

  11. 12-item version of World Health Organization Disability Assessment Schedule (WHODAS 2.0)

    Time frame: Day 0 and at one year

    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)

  12. Disability as measured with EDSS score

    Time frame: Day 0 and at one year

    To study the relationship between MYO motion data and physician-scored rated disability

  13. Disability as measured with Functional systems score (FS)

    Time frame: Day 0 and at one year

    To study the relationship between MYO motion data and physician-scored rated disability

  14. Dysfunction assessed by walking disorder status

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of walking disorder status is compared to MYO motion data.

  15. Dysfunction assessed by foot tapping test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of foot tapping test is compared to MYO motion data.

  16. Dysfunction assessed by finger tapping test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of finger tapping test is compared to MYO motion data.

  17. Dysfunction assessed by heel-knee test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of heel-knee test is compared to MYO motion data.

  18. Dysfunction assessed by Romberg test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of Romberg test is compared to MYO motion data.

  19. Dysfunction assessed by finger to nose test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of finger to nose test is compared to MYO motion data.

  20. Dysfunction assessed by timed 25 foot walk test result

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of timed 25 foot walk test is compared to MYO motion data.

  21. Dysfunction assessed by nine holes peg test

    Time frame: Day 0 and at one year

    Dysfunction assessed by clinical exam of nine holes peg test is compared to MYO motion data.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: MYO

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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