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

Last updated: February 6, 2024
Sponsor: University of Alberta
Overall Status: Trial Not Available

Phase

N/A

Condition

Memory Loss

Amyotrophic Lateral Sclerosis (Als)

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT05830214
Pro00125737
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

[PATIENTS] Inclusion Criteria:

  • Has ALS, classified as definite, probable, laboratory-supported probable, or possibleALS according to the revised El Escorial criteria or a related neurodegenerativedisorder including ALS-FTD, PLS, PMA or asymptomatic individuals with a known ALSmutation (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 andrespond to questionnaires

Exclusion

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 isalready 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 andrespond 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 isclinically 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

Study Design

Study Start date:
January 01, 2024
Estimated Completion Date:
February 06, 2024

Study 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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

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