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Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05711563
Acronym
POTA
Enrollment
50
Registered
2023-02-03
Start date
2023-11-30
Completion date
2025-11-30
Last updated
2023-02-03

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

Conditions

Autoimmune Encephalitis

Brief summary

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.

Interventions

OTHERObservational study

Observational study

Sponsors

University of Oxford
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional status1-3 yearsModified Rankin score
Seizure frequency1-3 years\>50% improvement in seizure frequency over time

Secondary

MeasureTime frameDescription
Clinical status1-3 yearsAs measured by the Clinical Assessment of severity in Autoimmune Encephalitis.
Mood/affect1-3 yearsMeasured by the hospital anxiety and depression index
Quality of life1-3 yearsEQ-5D-5L (By EuroQOL, not an abbreviation)
Pain1-3 yearsPatient-Reported Outcomes Measurement Information System (PROMIS) Pain interference short form A
Sleep Quality1-3 yearsPittsburgh Sleep Quality Index
Impulsivity1-3 yearsBarratt Impulsivity Index
Neuropsychiatric symptoms1-3 yearsNeuropsychiatric Inventory
Fatigue1-3 yearsFatigue Scale for Motor and Cognitive Funcitons
Cognitive ability1-3 yearsAs measured by the Addenbrooke's Cognitive Examination.

Other

MeasureTime frameDescription
Other symptoms1-3 yearsQualitiative analysis through semi-structured interview with participants and caregivers.

Contacts

Primary ContactMark Kelly, MB BCh BAO, MSc, MRCP
markkelly22@rcsi.com+353 1 809 2210
Backup ContactNorman Delanty, B.Sc., MB, FRCPI
normandelanty@beaumont.ie+353 1 809 2210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026