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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03369171

RC16_0391

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

64 participants in 1 patient group

patients with MYO armband

Experimental group

Treatment:

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