Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Healthy, Muscular Atrophy, Progressive, Primary Lateral Sclerosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Alberta
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\[PATIENTS\] 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep stage | Up to 1 year | Sleep stage in time in wake, light and deep stages as measured using the Health Gauge smartwatch worn by participants |
| Body Temperature | Up to 1 year | Body temperature in Degrees Celsius as measured by the Health Gauge smartwatch worn by the participant |
| Respiratory rate | Up to 1 year | Respiratory rate in breaths per minute as measured by the Health Gauge smartwatch worn by the participant |
| Oxygen saturation | Up to 1 year | Oxygen saturation in percent as measured using the Health Gauge smartwatch worn by participants |
| Heart rate | Up to 1 year | Heart rate in beats per minute as measured using the Health Gauge smartwatch worn by participants |
| Step count | Up to 1 year | Physical activity in step count as measured using the Health Gauge smartwatch worn by participants |
| Distance travelled | Up to 1 year | Physical activity in distance travelled (meters) as measured using the Health Gauge smartwatch worn by participants |
| Calories | Up to 1 year | Physical activity in calories as measured using the Health Gauge smartwatch worn by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10 Meter Walk | Baseline | 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. |
| 2-Minute Timed Walk Test (2MWT) | Baseline | The 2MWT assess overall gait function and endurance. The total distance travelled in 2 minutes is measured. |
| Changes in ALS Assessment Questionnaire (ALSAQ-40) Mobility Sub-score | Changes from baseline at 1 year | Changes in self-reported physical mobility over 1 year as measured using the ALSAQ-40 mobility sub-score, lower scores indicate better mobility. |
| Changes in Generalized Anxiety Disorder 7 (GAD-7) score | Changes from baseline at 1 year | 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). |
| Changes in ALSFRS-R Dyspnea and Orthopnea sub-scores | Changes from baseline at 1 year | 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). |
| Changes in Patient Health Questionnaire (PHQ-9) score | Changes from baseline at 1 year | 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). |
| Timed Up and Go (TUG) | Baseline | 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. |
Countries
Canada
Outcome results
None listed