Clinical trial NCT05781113: A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition
Official title: A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Disease Condition Through Home Monitoring of MS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Celestra Health Systems
Sponsor class: INDUSTRY
Collaborators: name: University of Ottawa
name: Barts & The London NHS Trust
name: The Ottawa Hospital
name: Brigham and Women's Hospital
First posted: 2023-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 90 PwMS equally spread across 3 sites / geographies, with approximately 10% of patients in the EDSS 0 to 2.5 range, 45% of patients in EDSS range 3-4.5 and 45% of patients in EDSS range 5 to 6.5 (some patients within this latter group will use walking supports in the form of AFOs, electronic foot braces, etc.).

Brief summary: To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.

Detailed description: Multiple sclerosis (MS) is lifelong autoimmune disease that is typically first diagnosed in young adults; MS affects the central nervous system and can result in various impairments, including walking, cognition, dexterity, sleep, vision and bladder control. Notably, impairments to gait are the most common and are identified as the most impactful to a person with MS's (PwMS's) quality of life. Furthermore, ambulation is a key metric used to assess the severity of MS and is the basis for the Expanded Disability Status Scale (EDSS) that represents the global standard for assessing a patient's MS condition. For these reasons, clinicians employ a variety of gait tests to assess the severity and progression of the disease, which require frequent clinical visits and lack objective measurements as compared to what can be measured in a laboratory setting. Current scales do not detect subtle progression that could be indicative of early transformation into Secondary Progressive MS (SPMS) from Relapsing Remitting MS (RRMS) or significant progression in progressive forms of MS.

With advancements in wearable technologies and Artificial Intelligence (AI)-based algorithm development, clinicians can be provided with meaningful laboratory grade gait metrics collected in the patient's home environment to assist their practice. Objective walking information can be provided to clinicians to track the personalized progression of the disease to enable a more targeted treatment plan. A subset of this data is also shared with the patients via their smart phone app to keep them informed and motivated.

Several times per week, smart insoles in the patient's shoes will collect data from the embedded sensors (pressure sensors, accelerometer, gyroscope). The wearable smart insoles are fitted into a pair of the patient's "everyday use" shoes, and are very similar to the type of "comfort" insoles available from a local pharmacy. The smart insole data will be used to create AI-based personalized models that compute each individual's walking signature; this includes tracking of subtle changes over time (improvement, deterioration) as well as identifying specific gait phenotypes.

Eligibility criteria: Inclusion Criteria:

* Participants must have a diagnosis of Multiple Sclerosis (MS) based on the McDonald criteria, within an age range of 18 to 60.
* The participant must have an Extended Disability Status Scale (EDSS) score at screening less than or equal to 6.5, inclusive.
* The participant cohort will include at least 3 participants at each site exhibiting one of the following gait phenotypes: ataxic, hemiplegic and spastic. (Some participants may exhibit more than one phenotype).
* The participant cohort will include at least 3 participants at each site with a progressive form of MS.

Exclusion Criteria:

* Participants that are currently suffering from a musculoskeletal injury (e.g., sprain, fracture, strain, etc.) that limits their ability to use their full range of motion of any joint at the time of recruitment.
* Inability to provide informed consent.

Primary outcomes:
measure: Participant Adherence
timeFrame: 6 months
measure: Clinician Acceptance
timeFrame: 6 months
Secondary outcomes:
measure: Gait Quality Measurement
timeFrame: 6 months
measure: Correlation between AI Gait Algorithms and Patience Perceptions
timeFrame: 6 months
measure: AI-based Identification of Gait Phenotypes
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
affiliation: The Ottawa Hospital
name: Gauruv Bose, Dr.
role: PRINCIPAL_INVESTIGATOR
References: