Autoimmune Encephalitis Clinical Trial
— LGI1-IRMOfficial title:
Investigating the Prognostic Role of Brain MRI in Anti-LGI1 Encephalitis
NCT number | NCT05825690 |
Other study ID # | 22-5017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 20, 2022 |
Est. completion date | December 20, 2022 |
Verified date | April 2023 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The term "autoimmune encephalitis" denotes an heterogenous group of diseases commonly associated with autoantibodies targeting neural or glial antigens. Patients harboring antibodies against the leucine-rich glioma-inactivated protein 1 (LGI1) usually respond well to immunotherapy, but a significant percentage develop cognitive sequelae and disability nonetheless. These patients would likely benefit for more aggressive and prolonged immunotherapy, aiming to prevent permanent neurological deficits. Identifying features predicting poor outcome would be crucial to guide treatment decisions. Brain magnetic resonance imaging is a key diagnostic tool in the acute phase, but radiological changes may also appear in follow-up studies, including global brain atrophy, hippocampal atrophy and mesial temporal sclerosis. We hypothesize that specific changes identifiable in the acute and chronic phase underlie a higher risk of poor outcome and persistent neurological deficits.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 20, 2022 |
Est. primary completion date | September 20, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - - Patients with a definite diagnosis of LGI1-antibody-associated encephalitis - available MRI records - Ascertained positivity for LGI1-antibodies in serum and/or CSF Exclusion Criteria: - - Positivity for another antibody against neural or glial antigens - MRI images not available - Not enough clinical data to ascertain outcome |
Country | Name | City | State |
---|---|---|---|
France | Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive dysfunction and disability | Main outcome measures will include cognitive dysfunction measured by appropriate neuropsychological evaluations, and psychiatric symptoms; it will be "none", "light", "moderate", "severe" | 12 months |
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