Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Autoimmune Encephalitis Clinical Trial

— POTA  

Official title:

Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05711563
• Other study ID #: 212573289
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: November 2025

Study information

• Verified date: January 2023
• Source: Royal College of Surgeons, Ireland
• Contact: Mark Kelly, MB BCh BAO, MSc, MRCP
• Phone: +353 1 809 2210
• Email: markkelly22[@]rcsi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other symptoms	Qualitiative analysis through semi-structured interview with participants and caregivers.	1-3 years
Primary	Seizure frequency	>50% improvement in seizure frequency over time	1-3 years
Primary	Functional status	Modified Rankin score	1-3 years
Secondary	Cognitive ability	As measured by the Addenbrooke's Cognitive Examination.	1-3 years
Secondary	Clinical status	As measured by the Clinical Assessment of severity in Autoimmune Encephalitis.	1-3 years
Secondary	Mood/affect	Measured by the hospital anxiety and depression index	1-3 years
Secondary	Quality of life	EQ-5D-5L (By EuroQOL, not an abbreviation)	1-3 years
Secondary	Pain	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain interference short form A	1-3 years
Secondary	Fatigue	Fatigue Scale for Motor and Cognitive Funcitons	1-3 years
Secondary	Fatigue	Modified Fatigue and Impact Scale	1-3 years
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index	1-3 years
Secondary	Impulsivity	Barratt Impulsivity Index	1-3 years
Secondary	Neuropsychiatric symptoms	Neuropsychiatric Inventory	1-3 years