Clinical trial NCT02802475: Antibodies Causing Epilepsy Syndromes: The ACES Study.
Official title: Antibodies Causing Epilepsy Syndromes: The ACES Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Auto-immune Encephalitis
Epilepsy
Keywords: antibodies
auto-immune encephalitis
epilepsy
limbic encephalitis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Nationaal Epilepsie Fonds
First posted: 2016-06-16
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with acquired chronic focal epilepsy without known cause or new onset status epilepticus or new onset seizures with signs of encephalitis and unknown cause.

Brief summary: The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.

Detailed description: Recently new treatable causes of epilepsy have been identified. These disorders are caused by a disruption of the balance in the brain caused by inflammation. This inflammatory reaction is caused by an autologous reaction of the immune system to specific brain proteins. The body produces antibodies to specific parts of the brain. These disorders can lead to epilepsy, memory dysfunction and psychiatric problems. Recognition is necessary for good treatment. Mostly anti-epileptic drugs are insufficient. These diseases can be treated with immune-modulating therapy. The ACES Study will focus on determining the frequencies of known antibodies and finding new, currently unknown, antibodies, causing epilepsy. Therefore patients will be investigated with epilepsy of unknown origin. To find new antibodies sera of patients with epilepsy will be added to brain sections of rats and to cultivated neuronal cells to look for a reaction. If new antibodies will be detected clinical features will be mapped of the patients. Also effects of antibodies on brain cells will be determined. Discovery of new antibodies can provide new treatment options for these patients. Also it will enable to discover more about the pathologic mechanisms of epilepsy.

Eligibility criteria: Inclusion Criteria:

* Age of 18 and older.
* Status epilepticus or new onset seizures with signs of limbic encephalitis (clinical picture, MRI (FLAIR abnormalities), EEG abnormalities or CSF findings (CSF pleocytosis, increased IgG index, oligoclonal bands), or:
* Patients with acquired chronic focal epilepsy with an unknown cause.

Exclusion Criteria:

* Children
* Epilepsy with known cause

Primary outcomes:
measure: frequency of patients with known and novel antibodies
timeFrame: 3 year
Secondary outcomes:
measure: modified Rankin scale
timeFrame: 1 year
measure: Seizure frequency
timeFrame: 1 year
measure: Treatment response
timeFrame: 3 months
Other outcomes:
Locations:
city: Heemstede
country: Netherlands
facility: Epilepsiecentrum Kempenhaeghe
city: Heemstede
country: Netherlands
facility: Stichting Epilepsie Instelling Nederland (SEIN)
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: The Hague
country: Netherlands
facility: Haga Hospital
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
affiliation: Erasmus Medical Center
name: Maarten J Titulaer, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: