Recruiting

Digital Tool

Sponsor:

Ad scientiam

Code:

NCT05566769

Conditions

Neuromyelitis Optica

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NMOSDCopilot smartphone application

Study Details

Brief 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.

Conditions

Neuromyelitis Optica

Study ID

NCT05566769

Start date

Nov 3, 2023

Status verified date

Apr, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

103 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: NMOSDCopilot

Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months

Interventions

NMOSDCopilot smartphone application

NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression

Primary outcome measure

  • To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test [ Time Frame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days ]

Central Contacts and Locations

Central contacts

Dr Levy

617-726-7565mlevy11@mgh.harvard.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Dr Lilyana Amezcua

323 442-5710lamezcua@usc.edu

Principal Investigator:

Dr Amezcua

University of California Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Dr Apperson

800 282 3284mlapperson@ucdavis.edu

Principal Investigator:

Dr Apperson

University of south Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

John Ciotti, MD

8133969478jciotti@usf.edu

Principal Investigator:

Dr Ciotti

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Afif Hentati, MD

+1 847-570-2570AHentati@northshore.org

Principal Investigator:

Dr Hentati

Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Elias S Sotirchos

410-614-1522ess@jhmi.edu

Principal Investigator:

Dr Sotirchos

Massachussets General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Levy, MD, PhD

(617) 726-7565MLEVY11@mgh.harvard.edu

Principal Investigator:

Dr Levy

Washington University in St. Louis

Recruiting

Washington, Missouri, United States, 63130

Contacts

Robert T Naismith, MD

314-362-3293naismithr@wustl.edu

Principal Investigator:

Dr Naismith

CC Lou Ruvo Center for Brain Health

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Le Hua, MD

7024836000Hual@ccf.org

Principal Investigator:

Dr Le Hua

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Dr Dujmovic

984 974-4401irdujm@neurology.unc.edu

Principal Investigator:

Dr Dujmovic

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Gabriel Pardo, MD

(405) 271-6673gabriel-pardo@omrf.org

More Information

Sponsor

Ad scientiam

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Keywords

  • NMO
  • NMOSD
  • Neuromyelitis optica
  • Neuromyelitis optica spectrum disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ad scientiam on 2025-04-10.