Not currently recruiting at University of California Health

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

a study on Neuromyelitis Optica Spectrum Disorders

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms.

The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.

Official Title

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder

Keywords

Neuromyelitis Optica, NMO, NMOSD, Neuromyelitis optica spectrum disorder, NMOSDCopilot smartphone application, NMOSDCopilot

Eligibility

You can join if…

Open to people ages 18 years and up

  • Aged over 18 years old
  • NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
  • With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
  • EDSS =< 7
  • With no evidence of relapse in the past 3 months before enrollment
  • Who have read the information sheet and signed the informed consent form
  • Able to use a smartphone
  • Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
  • Able to read language in which the mobile application is available and able to understand pictograms

You CAN'T join if...

  • Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
  • Pregnant and nursing women
  • Person under guardianship or curatorship
  • Bedridden patients or patients with a daily activity of less than 2 hours per day
  • Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  • Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.

Locations

  • University of California Davis Health not yet accepting patients
    Sacramento California 95817 United States
  • University of Southern California not yet accepting patients
    Los Angeles California 90033 United States
  • CC Lou Ruvo Center for Brain Health accepting new patients
    Las Vegas Nevada 89106 United States
  • Oklahoma Medical Research Foundation accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Ad scientiam
ID
NCT05566769
Study Type
Interventional
Participants
Expecting 103 study participants
Last Updated