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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoimmune Encephalitis (Ireland) |
| ||
| Autoimmune Encephalitis (UK) |
| ||
| Other neurological controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | Observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | >50% improvement in seizure frequency over time | 1-3 years |
| Functional status | Modified Rankin score | 1-3 years |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Other symptoms | Qualitiative analysis through semi-structured interview with participants and caregivers. | 1-3 years |
Inclusion Criteria:
Exclusion Criteria:
AE participants
Other neurological control participants will be excluded if they have a current or historic diagnosis of AE.
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Participants with probable or definite autoimmune encephalitis will be recruited via the Oxford Autoimmune Neurology Group in the UK and Beaumont Hospital in Ireland.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Kelly, MB BCh BAO, MSc, MRCP | Contact | +353 1 809 2210 | markkelly22@rcsi.com | |
| Norman Delanty, B.Sc., MB, FRCPI | Contact | +353 1 809 2210 | normandelanty@beaumont.ie |
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Data or samples may (with consent) be shared in coded format with other ethically approved research studies, relating to disorders of the nervous system.
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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).
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| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Serum and CSF
| 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 |