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

NCT ID: NCT05830214

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-02-06

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• 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

• 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]

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jake Hayward, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00125737

Identifier Type: -

Identifier Source: org_study_id