Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS

University of Alberta

Overview

This observational study will use new smartwatch technology to continuously and remotely monitor the health of ALS patients and healthy controls over time. This information will be used to develop digital biomarkers for ALS.

This is an optional study that is conducted in parallel to CAPTURE ALS (NCT05204017). In this exploratory, prospective, longitudinal study, CAPTURE ALS participants undergo remote physiological data collection using smartwatch technology. Participants will wear a specialized smartwatch (Health Gauge AI-Based Wearable Device ) for the duration of the study. ALS patients will be followed for 12 months, healthy controls will be followed for 8 months. Digital questionnaires will monitor participant-related outcomes bi-monthly. Gait assessments will be performed by ambulatory patients and healthy controls in clinic during CAPTURE ALS study visits to measure changes in walking activity.

Study Type

OBSERVATIONAL

Conditions

Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Muscular Atrophy, Progressive Frontotemporal Dementia Healthy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

\[PATIENTS\] Inclusion Criteria: * Has ALS, classified as definite, probable, laboratory-supported probable, or possible ALS according to the revised El Escorial criteria or a related neurodegenerative disorder including ALS-FTD, PLS, PMA or asymptomatic individuals with a known ALS mutation (as previously confirmed during the individual's regular clinical care) * Is the age of majority in their province of residence/treatment * Has the cognitive capacity to provide informed consent * Has proficiency in English or French in order to understand study instructions and respond to questionnaires Exclusion Criteria: * Is pregnant * Has a history of active (clinically significant) skin disorders * Has a history of allergic response to plastic materials * Has an electronic implant of any kind (e.g. pacemaker) * Has broken, damaged or irritated skin or rashes near the sensor application sites * Is unstably housed or lack reliable contact information. * Investigator judges that device retrieval will be difficult or unlikely * Does not have a smartphone that will support the HG application * Does not have daily access to a wireless connection \[HEALTHY CONTROLS\] Inclusion Criteria: * Be between the ages of 40-80 unless age matched to a patient (+/-3 years) who is already enrolled. * Is the age of majority in their province of residence/treatment * Has the cognitive capacity to provide informed consent * Has proficiency in English or French in order to understand study instructions and respond to questionnaires Exclusion Criteria: * Has a history of a neurological disease, including Central Nervous System disease (e.g., stroke, head injury, epilepsy) or Peripheral Nervous System disease (neuropathy, myopathy). * Has a history of psychiatric disease (e.g., depression, bipolar disease) that is clinically diagnosed and/or with the current use of psychiatric medications (e.g., antidepressants) for an indication of a psychiatric disease. * Is pregnant * Has a history of active (clinically significant) skin disorders * Has a history of allergic response to plastic materials * Has an electronic implant of any kind (e.g. pacemaker) * Has broken, damaged or irritated skin or rashes near the sensor application sites * Is unstably housed or lack reliable contact information. * Investigator judges that device retrieval will be difficult or unlikely * Does not have a smartphone that will support the HG application * Does not have daily access to a wireless connection

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Body Temperature

Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant

Time frame: Up to 1 year

Respiratory rate

Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant

Time frame: Up to 1 year

Oxygen saturation

Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Heart rate

Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Step count

Physical activity in step count as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Distance travelled

Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Calories

Physical activity in calories as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Sleep stage

Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants

Time frame: Up to 1 year

Secondary Outcomes

Data from ClinicalTrials.gov

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Timed Up and Go (TUG)

The TUG is used to assess changes in functional mobility. Participants arise from a chair, walk forward 3 meters, turn around, walk back to the chair and sit. The time to complete the test is measured.

Time frame: Baseline

Timed Up and Go (TUG)

Time frame: Month 4

Timed Up and Go (TUG)

Time frame: Month 8

Timed Up and Go (TUG)

Time frame: Month 12

10 Meter Walk

The 10 Meter Walk Test is a performance measure used to assess walking speed over a short distance. This task will be performed with and without serial 3s subtraction. The time to walk 10 meters and the number of errors in the mental task are measured.

Time frame: Baseline

10 Meter Walk

Time frame: 4 Months

10 Meter Walk

Time frame: 8 Months

10 Meter Walk

Time frame: 12 Months

2-Minute Timed Walk Test (2MWT)

The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

Time frame: Baseline

2-Minute Timed Walk Test (2MWT)

The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

Time frame: 4 Months

2-Minute Timed Walk Test (2MWT)

The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

Time frame: 8 Months

2-Minute Timed Walk Test (2MWT)

The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured.

Time frame: 12 Months

Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score

Changes in self-reported physical mobility over 1 year as measured using the ALSAQ-40 mobility sub-score, lower scores indicate better mobility.

Time frame: Changes from baseline at 1 year

Changes in Generalized Anxiety Disorder 7 (GAD-7) score

Changes in self-reported anxiety over 1 year as measured using the GAD-7. The total score for the 7 items ranges from 0-21, with 0-4 (none to minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).

Time frame: Changes from baseline at 1 year

Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores

Changes in self-reported dyspnea and orthopnea over 1 year as measured using the ALS Functional Rating Scale dyspnea and orthopnea sub-scores. Each question is scored by the participant as "4" (never) to "0" (all of the time).

Time frame: Changes from baseline at 1 year

Changes in Patient Health Questionnaire (PHQ-9) score

Changes in self-reported depression over 1 year as measured using the PHQ-9. The total score for the 9 items ranges from 0-27, with 0-4 (none-minimal depression), 5-9 (mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression), 20-27 (severe).

Time frame: Changes from baseline at 1 year