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Exploratory Research on Digital Biomarkers in Neuroimmune Disorders

Exploratory Research on Digital Biomarkers in Neuroimmune Disorders - Intervention Study with Data Extraction using Digital Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051480
Enrollment
130
Registered
2023-07-01
Start date
2023-07-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological disease

Interventions

None listed

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study focuses on patients with multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), and myasthenia gravis (MG) who have the capacity for autonomous decision-making during their hospital visits. For patients under the age of 18 with decision-making capacity, their participation will be subject to obtaining consent from their parents. Healthy volunteers for comparison will be individuals who have provided informed consent to participate in the study. The diagnostic criteria and inclusion criteria for each disease are as follows: MS: Patients diagnosed according to the 2017 McDonald diagnostic criteria for MS. NMOSD: Patients diagnosed with NMOSD and tested positive for anti-aquaporin-4 antibodies, in accordance with the 2015 international diagnostic criteria for NMOSD. MG: Patients diagnosed with myasthenia gravis based on the 2022 Guidelines for the Treatment of Myasthenia Gravis, either with positive anti-acetylcholine receptor antibodies or positive MuSK antibodies.

Exclusion criteria

Exclusion criteria: Patients under 15 years of age Patients whose attending physician determines that participation in this study is inappropriate

Design outcomes

Primary

MeasureTime frame
Exploratory research on the correlation between electronic Patient-Reported Outcomes (ePRO) and Personal Health Records (PHR) with background information, disease information, physical examination findings, and test results.

Countries

Japan

Contacts

Public ContactKenzo Sakurai

St. Marianna University School of Medicine Department of Neurology

k2sakurai@marianna-u.ac.jp+81449778111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026