Study Purpose:
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.Study Status:
Not yet recruiting
Disease:
Amyotrophic Lateral Sclerosis , Primary Lateral Sclerosis , Muscular Atrophy, Progressive , Frontotemporal Dementia , Healthy
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jake Hayward, MD, University of Alberta
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Sara Moradipoor / email hidden; JavaScript is required / 780-248-1805
Full Study Summary:
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 Sponsor:
University of Alberta
Estimated Enrollment:
42
Estimated Study Start Date:
09 / 01 / 2023
Estimated Study Completion Date:
08 / 01 / 2025
Posting Last Modified Date:
05 / 16 / 2023
Date Study Added to neals.org:
04 / 26 / 2023
Accepts healthy volunteers:
Yes
Minimum Age:
18 Years
Maximum Age:
N/A
[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
University of Alberta
Sara Moradipoor / 780-248-1805 / email hidden; JavaScript is required
Edmonton, Alberta
T6G 2B7
Canada