Clinical trial NCT03369171: Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
Official title: Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discrimination of walking disorder status
timeFrame: Day 0
Secondary outcomes:
measure: Foot tapping test
timeFrame: day 0
measure: Finger tapping test
timeFrame: day 0
measure: Heel-knee test
timeFrame: day 0
measure: Romberg test
timeFrame: day 0
measure: Finger to nose test
timeFrame: day 0
measure: Timed 25 foot walk test result
timeFrame: day 0
measure: Nine holes peg test
timeFrame: day 0
measure: Expanded disability status scores (EDSS)
timeFrame: Day 0 and at one year
measure: Patient-reported disability using self-report questionnaire
timeFrame: Day 0 and at one year
measure: Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale
timeFrame: Day 0 and at one year
measure: 12-item version of World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Day 0 and at one year
measure: Disability as measured with EDSS score
timeFrame: Day 0 and at one year
measure: Disability as measured with Functional systems score (FS)
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by walking disorder status
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by foot tapping test
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by finger tapping test
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by heel-knee test
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by Romberg test
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by finger to nose test
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by timed 25 foot walk test result
timeFrame: Day 0 and at one year
measure: Dysfunction assessed by nine holes peg test
timeFrame: Day 0 and at one year
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: David Laplaud, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: