Predicting and Monitoring Outcomes in Autoimmune Encephalitis

NCT ID: NCT05711563

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-11-30

Brief Summary

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Epilepsy is a disorder of the brain in which people have repeated seizures.

Autoimmune encephalitis (AE) is a rare cause of epilepsy. It is an inflammatory disease of the brain. This means that the body's own immune system attacks healthy brain tissue, just like it would if it were infected by a virus or a bacteria, by producing an army of proteins called 'antibodies' which go on to 'attack' healthy tissues.

Seizures in AE typically do not respond well to classic 'anti-seizure medications'. Instead, medications which suppress the immune system are used. These can have significant side-effects and some patients will still continue to have seizures or experience a recurrence of AE-related epilepsy despite treatment. It is difficult to accurately predict who will experience these outcomes.

This study aims to find ways of predicting and monitoring which people with AE are at greatest risk of these outcomes, so we can better direct them towards appropriate treatments. We will collect clinical information and samples of blood and cerebrospinal fluid (CSF, fluid surrounding the brain and spinal cord) from people with AE and 'control' participants with other neurological illnesses. Samples will be analysed for markers which may help predict or correlate with outcomes in AE and better understand this condition.

Detailed Description

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Conditions

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Autoimmune Encephalitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Autoimmune Encephalitis (Ireland)

Observational study

Intervention Type OTHER

Observational study

Autoimmune Encephalitis (UK)

Observational study

Intervention Type OTHER

Observational study

Other neurological controls

Observational study

Intervention Type OTHER

Observational study

Interventions

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Observational study

Observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* AE participants over the age of 18 will be recruited if they meet the criteria for clinically probable or clinically definite Autoimmune Encephalitis as per Graus and colleagues 2016.
* Neurological Control participants undergoing lumbar puncture as part of clinical care for other, non-encephalitis disorders (e.g. for investigation of headache where meningitis or encephalitis is not detected, for investigation and treatment of idiopathic intracranial hypertension) in Beaumont hospital will be recruited.

Exclusion Criteria

AE participants

* Under 18 years of age
* Participants without AE or those with a definitive alternate diagnosis for presentation.

Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Mark Kelly, MB BCh BAO, MSc, MRCP

Role: CONTACT

+353 1 809 2210

Norman Delanty, B.Sc., MB, FRCPI

Role: CONTACT

+353 1 809 2210

Other Identifiers

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212573289

Identifier Type: -

Identifier Source: org_study_id

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