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Patient Reported Outcomes while Manipulating the Immune System in autoimmune Encephalitis

Patient Reported Outcomes while Manipulating the Immune System in autoimmune Encephalitis - The PROMISE study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50854
Enrollment
500
Registered
2021-06-18
Start date
2021-09-19
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

autoimmune encephalitis autoimmune inflammation of the brain Brain inflammation

Interventions

To evaluate existing PROMS, developed for other (neurological) disease, for&nbsp
patients with an autoimmune encephalitis.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults or adolescents from the age of 16 years; 2. Sufficiently fluent in Dutch; 3. Have a clinical high suspicion of an autoimmune encephalitis or a paraneoplastic neurological syndrome 4. Antibodies are detected in serum and/or CSF with cell-based assay and affirmed with immunohistochemistry

Exclusion criteria

Exclusion criteria: 1. Impossible to assess outcome related to autoimmune encephalitis due to pre-existing comorbidities, objectified as a premorbid mRS over two. 2. The patient and/or legal representative is withholding informed consent; 3. The patient withdraws, after initial consent.

Design outcomes

Primary

MeasureTime frame
The outcome of patients with an autoimmune encephalitis over time, also per subtype of autoimmune encephalitis.

Secondary

MeasureTime frame
Disease-specific valid patient-reported outcome measure(s), with discriminatory value in the acute as well as the chronic phase of the disease.

Countries

Netherlands

Contacts

Public ContactM.J. Titulaer

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.titulaer@erasmusmc.nl010 7030864

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026