Neuromyelitis OpticaOPTISNCT05566769
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
A study testing NMOSDCopilot smartphone application in people with Neuromyelitis Optica, run by Ad scientiam at 22 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica
- What is being tested?
- NMOSDCopilot smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 3 Nov 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Baltimore, Maryland, 21287
Elias S Sotirchos, 410-614-1522, ess@jhmi.edu
Dr Sotirchos
- Recruiting
Massachussets General Hospital
Boston, Massachusetts, 02114
Michael Levy, MD, PhD, (617) 726-7565, MLEVY11@mgh.harvard.edu
Dr Levy
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Dr Dujmovic, 984 974-4401, irdujm@neurology.unc.edu
Dr Dujmovic
- Recruiting
NorthShore University HealthSystem
Evanston, Illinois, 60201
Afif Hentati, MD, +1 847-570-2570, AHentati@northshore.org
Dr Hentati
- Recruiting
CC Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Le Hua, MD, 7024836000, Hual@ccf.org
Dr Le Hua
- Recruiting
University of Southern California
Los Angeles, California, 90033
Dr Lilyana Amezcua, 323 442-5710, lamezcua@usc.edu
Dr Amezcua
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Gabriel Pardo, MD, (405) 271-6673, gabriel-pardo@omrf.org
- Recruiting
University of California Davis Health
Sacramento, California, 95817
Dr Apperson, 800 282 3284, mlapperson@ucdavis.edu
Dr Apperson
- Recruiting
University of south Florida
Tampa, Florida, 33612
John Ciotti, MD, 8133969478, jciotti@usf.edu
Dr Ciotti
- Recruiting
Washington University in St. Louis
Washington, Missouri, 63130
Robert T Naismith, MD, 314-362-3293, naismithr@wustl.edu
Dr Naismith
France8 sites, 6 recruiting
- Recruiting
Hôpital Roger Salengro
Lille, 59037
Helene Zephir, Pr, 03 20 44 59 62, Helene.ZEPHIR@chu-lille.fr
- Recruiting
CHU Marseille - La Timone
Marseille, 13385
Dr Maarouf, 04.91.38.00.00, Adil.MAAROUF@ap-hm.fr
Dr Maarouf
- Recruiting
CHU de Montpellier
Montpellier, 34295
Pierre Labauge, Pr, 04 67 33 94 69, p-labauge@chu-montpellier.fr
- Recruiting
Hopital Pasteur 2
Nice, 06000
Michael Cohen, Dr, 04 92 03 77 77, cohen.m@chu-nice.fr
- Recruiting
Hopital La Pitié Salpétrière
Paris
Elisabeth Maillart, Dr, 01 42 17 62 05, elisabeth.maillart@aphp.fr
- Active, not recruiting
CHU Rouen
Rouen, 76038
- Completed
Hopital de Hautepierre
Strasbourg, 67000
- Recruiting
CHU Toulouse - Hôpital Purpan
Toulouse, 31059
Dr Ciron, +33 5 61 77 91 06, ciron.j@chu-toulouse.fr
Dr Ciron
Germany4 sites, 4 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, 01397
Dr Ziemssen, +49 (0) 351 458 7450, Tjalf.Ziemssen@ukdd.de
Dr Ziemssen
- Recruiting
Universitätsklinik Essen
Essen, 45147
Dr Pul, +49 201 / 723- 82382, refik.pul@uk-essen.de
Dr Pul
- Recruiting
University Munich
Munich, 80336
Dr Havla, +49 89 4400 74781, joachim.havla@med.lmu.de
Dr Havla
- Not yet recruiting
Hopital Rechts der Isar der Technischen Universitat Munchen
Munich
Achim Berthele, Dr, +49 89 41400, achim.berthele@tum.de
About this study
Official title: Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
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
- Being tested
- NMOSDCopilot smartphone application
- Keywords
- NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMOSDCopilot smartphone applicationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| NMOSDCopilot | Experimental | Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months Receives: Device: NMOSDCopilot smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline
Measured: Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Secondary outcomes (14)
To assess reproducibility between in-clinic and at-home e-active tests
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline and between and month 6 and month 6- 7days
Measured: Baseline, day 7, month 6 - 7 days, month 6
To assess test-retest reliability of at-home e-active tests
Intraclass correlation coefficient of e-active tests
Measured: Month 1, month 2, month 3, month 4, month 5
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests
Measured: Baseline, month 6, month 12
To assess the adverse events related to of the mobile application use.
descriptive analysis of adverse events (AEs) related to the use of the application.
Measured: through study completion, 21 months
To assess pain
Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome
Measured: Month 3, month 6, month 12
To assess fatigue
Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome
Measured: Month 3, month 6, month 12
To assess bladder control
Bladder Control Scale (0-22) higher score meaning a worse outcome
Measured: Month 3, month 6, month 12
To assess bowel control
Bowel Control Scale (0-22) higher score meaning a worse outcome
Measured: Month 3, month 6, month 12
To assess depression
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
Measured: Month 3, month 6, month 12
To assess quality of life
p-value of multivariate analysis for non-parametric data
Measured: Baseline, month 6, month 12
To assess disability
Expanded Disability Status Scale (0-10), higher score meaning a worse outcome
Measured: Baseline, month 6, month 12
To assess satisfaction and user experience with the smartphone application and the web dashboard
Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)
Measured: Through study completion, 21 months
To assess at-home compliance and adherence to the patient application
Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).
Measured: Through study completion, 21 months
To compare results obtained with at home MVT and in-clinic OCT-scan
The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF \& GCIP layer thickness
Measured: Through study completion, 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start3 Nov 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566769
- Sponsor's protocol ID
- OPTIS
- Acronym
- OPTIS
- Status last verified
- Apr 2025
- First submitted
- 7 Sep 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05566769
- Acronym / sponsor ID
- OPTIS / OPTIS
- Conditions
- Neuromyelitis Optica
- Keywords
- NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group
| Arm | Type | Receives |
|---|---|---|
| NMOSDCopilot | Experimental | Device: NMOSDCopilot smartphone applicationPerformance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMOSDCopilot smartphone applicationNMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression | Device | NMOSDCopilot |
Primary outcome
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
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline
14 secondary outcomes
To assess reproducibility between in-clinic and at-home e-active tests
Time frame: Baseline, day 7, month 6 - 7 days, month 6
To assess test-retest reliability of at-home e-active tests
Time frame: Month 1, month 2, month 3, month 4, month 5
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Time frame: Baseline, month 6, month 12
To assess the adverse events related to of the mobile application use.
Time frame: through study completion, 21 months
To assess pain
Time frame: Month 3, month 6, month 12
To assess fatigue
Time frame: Month 3, month 6, month 12
To assess bladder control
Time frame: Month 3, month 6, month 12
To assess bowel control
Time frame: Month 3, month 6, month 12
To assess depression
Time frame: Month 3, month 6, month 12
To assess quality of life
Time frame: Baseline, month 6, month 12
To assess disability
Time frame: Baseline, month 6, month 12
To assess satisfaction and user experience with the smartphone application and the web dashboard
Time frame: Through study completion, 21 months
To assess at-home compliance and adherence to the patient application
Time frame: Through study completion, 21 months
To compare results obtained with at home MVT and in-clinic OCT-scan
Time frame: Through study completion, 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMOSDCopilot smartphone application in people with Neuromyelitis Optica, run by Ad scientiam at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Levy (617-726-7565, mlevy11@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.