Clinical trial NCT05711563: Predicting and Monitoring Outcomes in Autoimmune Encephalitis
Official title: Predicting and Monitoring Outcomes in Autoimmune Encephalitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Encephalitis
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2023-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with probable or definite autoimmune encephalitis will be recruited via the Oxford Autoimmune Neurology Group in the UK and Beaumont Hospital in Ireland.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seizure frequency
timeFrame: 1-3 years
measure: Functional status
timeFrame: 1-3 years
Secondary outcomes:
measure: Cognitive ability
timeFrame: 1-3 years
measure: Clinical status
timeFrame: 1-3 years
measure: Mood/affect
timeFrame: 1-3 years
measure: Quality of life
timeFrame: 1-3 years
measure: Pain
timeFrame: 1-3 years
measure: Fatigue
timeFrame: 1-3 years
measure: Fatigue
timeFrame: 1-3 years
measure: Sleep Quality
timeFrame: 1-3 years
measure: Impulsivity
timeFrame: 1-3 years
measure: Neuropsychiatric symptoms
timeFrame: 1-3 years
Other outcomes:
measure: Other symptoms
timeFrame: 1-3 years
Locations:
Study officials:
References: