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NCT05830214Withdrawn

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

Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS (CAPTURE ALS Smarwatch)

Source: ClinicalTrials.gov · Last updated 8 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Observational
Enrollment
0 (actual)
First submitted
24 Feb 2023
Start date
Jan 2024
Primary completion date
6 Feb 2024
Lead sponsor
University of Alberta
NCT number
NCT05830214

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has an electronic implant of any kind (e.g. pacemaker)
  • Has an electronic implant of any kind (e.g. pacemaker)

Other illness

  • Has a history of active (clinically significant) skin disorders
  • Has a history of allergic response to plastic materials
  • 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.
  • Has a history of active (clinically significant) skin disorders
  • Has a history of allergic response to plastic materials

Other

  • Is pregnant
  • 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]
  • Is pregnant
  • 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

Who the study is looking for

  • 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

Criteria the registry did not label

  • [PATIENTS]

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of AlbertaEdmontonCanadaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.