Predicting and Monitoring Outcomes in Autoimmune Encephalitis (POTA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autoimmune Encephalitis
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Mark Kelly, MB BCh BAO, MSc, MRCP; Phone Number: +353 1 809 2210; Email: markkelly22@rcsi.com
• Study Contact Backup: Name: Norman Delanty, B.Sc., MB, FRCPI; Phone Number: +353 1 809 2210; Email: normandelanty@beaumont.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autoimmune Encephalitis (Ireland)	Other: Observational study; Observational study
Autoimmune Encephalitis (UK)	Other: Observational study; Observational study
Other neurological controls	Other: Observational study; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency	>50% improvement in seizure frequency over time	1-3 years
Functional status	Modified Rankin score	1-3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other symptoms	Qualitiative analysis through semi-structured interview with participants and caregivers.	1-3 years

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: University of Oxford

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2023
• Primary Completion (ANTICIPATED): November 1, 2025
• Study Completion (ANTICIPATED): November 1, 2025

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ACTUAL): February 3, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Encephalitis; Hashimoto Disease
• Other Study ID Numbers: 212573289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data or samples may (with consent) be shared in coded format with other ethically approved research studies, relating to disorders of the nervous system.
• IPD Sharing Access Criteria: Ethically approved studies which will process and dispose of data under the same regulations required by General Data Protection Regulation (GDPR) in Ireland and the European Union (EU).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No