NCT05566769 Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
| NCT ID | NCT05566769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ad scientiam |
| Condition | Neuromyelitis Optica |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 103 participants in total. It began in 2023-11-03 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05566769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromyelitis Optica. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05566769 currently recruiting?
Yes, NCT05566769 is actively recruiting participants. Contact the research team at mlevy11@mgh.harvard.edu for enrollment information.
Where is the NCT05566769 trial being conducted?
This trial is being conducted at Los Angeles, United States, Sacramento, United States, Tampa, United States, Evanston, United States and 11 additional locations.
Who is sponsoring the NCT05566769 clinical trial?
NCT05566769 is sponsored by Ad scientiam. The trial plans to enroll 103 participants.