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

Multiple Sclerosis Clinical Trial

— MYO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369171
• Other study ID #: RC16_0391
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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