Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Not yet recruiting

• Conditions: Autoimmune Encephalitis
• Interventions: Other: Observational study

• Registration Number: NCT05711563
• Lead Sponsor: Royal College of Surgeons, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Study Start: 2023-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autoimmune Encephalitis (Ireland)	Observational study	-
Autoimmune Encephalitis (UK)	Observational study	-
Other neurological controls	Observational study	-

Primary Outcome Measures

Name	Time	Method
Seizure frequency	1-3 years	\>50% improvement in seizure frequency over time
Functional status	1-3 years	Modified Rankin score

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	1-3 years	Pittsburgh Sleep Quality Index
Quality of life	1-3 years	EQ-5D-5L (By EuroQOL, not an abbreviation)
Cognitive ability	1-3 years	As measured by the Addenbrooke's Cognitive Examination.
Clinical status	1-3 years	As measured by the Clinical Assessment of severity in Autoimmune Encephalitis.
Mood/affect	1-3 years	Measured by the hospital anxiety and depression index
Pain	1-3 years	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain interference short form A
Fatigue	1-3 years	Modified Fatigue and Impact Scale
Impulsivity	1-3 years	Barratt Impulsivity Index
Neuropsychiatric symptoms	1-3 years	Neuropsychiatric Inventory