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Clinical Trials/NCT05711563
NCT05711563
Not yet recruiting
Not Applicable

Predicting and Monitoring Outcomes in Autoimmune Encephalitis

Royal College of Surgeons, Ireland0 sites50 target enrollmentNovember 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autoimmune Encephalitis
Sponsor
Royal College of Surgeons, Ireland
Enrollment
50
Primary Endpoint
Seizure frequency
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2023
End Date
November 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Royal College of Surgeons, Ireland
Responsible Party
Sponsor

Eligibility 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
  • 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.

Outcomes

Primary Outcomes

Seizure frequency

Time Frame: 1-3 years

\>50% improvement in seizure frequency over time

Functional status

Time Frame: 1-3 years

Modified Rankin score

Secondary Outcomes

  • Sleep Quality(1-3 years)
  • Quality of life(1-3 years)
  • Cognitive ability(1-3 years)
  • Clinical status(1-3 years)
  • Mood/affect(1-3 years)
  • Pain(1-3 years)
  • Fatigue(1-3 years)
  • Impulsivity(1-3 years)
  • Neuropsychiatric symptoms(1-3 years)

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