POTA: Predicting and Monitoring Outcomes in Autoimmune Encephalitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Seizure frequency [1-3 years]
>50% improvement in seizure frequency over time
- Functional status [1-3 years]
Modified Rankin score
Secondary Outcome Measures
- 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
- Quality of life [1-3 years]
EQ-5D-5L (By EuroQOL, not an abbreviation)
- Pain [1-3 years]
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain interference short form A
- Fatigue [1-3 years]
Fatigue Scale for Motor and Cognitive Funcitons
- Fatigue [1-3 years]
Modified Fatigue and Impact Scale
- Sleep Quality [1-3 years]
Pittsburgh Sleep Quality Index
- Impulsivity [1-3 years]
Barratt Impulsivity Index
- Neuropsychiatric symptoms [1-3 years]
Neuropsychiatric Inventory
Other Outcome Measures
- Other symptoms [1-3 years]
Qualitiative analysis through semi-structured interview with participants and caregivers.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Royal College of Surgeons, Ireland
- University of Oxford
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 212573289