Multiple SclerosisMYONCT03369171
Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
A study testing Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) in people with Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women
- Minors
- Adults under guardianship
- Adults over 64 years
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)Device
Also called MYO, Gesture control armband
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).
| Study group | Role | What they receive |
|---|---|---|
| patients with MYO armband | Experimental | Not described Receives: Device: Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start23 Jan 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Laplaud, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369171
- Sponsor's protocol ID
- RC16_0391
- Acronym
- MYO
- Status last verified
- May 2020
- First submitted
- 31 Oct 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03369171
- Acronym / sponsor ID
- MYO / RC16_0391
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with MYO armband | Experimental | Device: Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant women
- Minors
- Adults under guardianship
- Adults over 64 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)Also: MYO, Gesture control armbandMYO 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). | Device | patients with MYO armband |
Primary outcome
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).
21 secondary outcomes
Foot tapping test
Time frame: day 0
Finger tapping test
Time frame: day 0
Heel-knee test
Time frame: day 0
Romberg test
Time frame: day 0
Finger to nose test
Time frame: day 0
Timed 25 foot walk test result
Time frame: day 0
Nine holes peg test
Time frame: day 0
Expanded disability status scores (EDSS)
Time frame: Day 0 and at one year
Patient-reported disability using self-report questionnaire
Time frame: Day 0 and at one year
Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale
Time frame: Day 0 and at one year
12-item version of World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: Day 0 and at one year
Disability as measured with EDSS score
Time frame: Day 0 and at one year
Disability as measured with Functional systems score (FS)
Time frame: Day 0 and at one year
Dysfunction assessed by walking disorder status
Time frame: Day 0 and at one year
Dysfunction assessed by foot tapping test
Time frame: Day 0 and at one year
Dysfunction assessed by finger tapping test
Time frame: Day 0 and at one year
Dysfunction assessed by heel-knee test
Time frame: Day 0 and at one year
Dysfunction assessed by Romberg test
Time frame: Day 0 and at one year
Dysfunction assessed by finger to nose test
Time frame: Day 0 and at one year
Dysfunction assessed by timed 25 foot walk test result
Time frame: Day 0 and at one year
Dysfunction assessed by nine holes peg test
Time frame: Day 0 and at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Laplaud, PU-PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) in people with Multiple Sclerosis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discrimination of walking disorder status (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.