Antibodies Causing Epilepsy Syndromes: The ACES Study.

Completed

• Conditions: Auto-immune Encephalitis; Epilepsy
• Interventions: Biological: vena punction

• Registration Number: NCT02802475
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Primary Completion: 2019-12
• Study Completion: 2020-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acquired chronic, focal, epilepsy	vena punction	patients ≥18 years of age, with acquired chronic epilepsy of unknown origin
new onset epilepsy	vena punction	patients ≥18 years of age, with new onset status epilepticus or new onset seizures with suspicion of limbic encephalitis

Primary Outcome Measures

Name	Time	Method
frequency of patients with known and novel antibodies	3 year	detection of specific known and novel, currently unknown, auto-antibodies by immunohistochemistry, live hippocampal neuron cultures and cell-based assay

Secondary Outcome Measures

Name	Time	Method
modified Rankin scale	1 year	outcome 1 year after inclusion in the study
Seizure frequency	1 year	seizure frequency 1 year after inclusion in the study
Treatment response	3 months	frequency of objective improvement of outcome (seizure frequency, modified Rankin Scale) after immunotherapy, as compared to matched controls (without antibodies) from our study to exclude an effect due to regression to the mean or natural nistory.

Trial Locations

Locations (8)

St. Elisabeth Hospital; 🇳🇱 Tilburg, Netherlands

Academic Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands

Epilepsiecentrum Kempenhaeghe; 🇳🇱 Heemstede, Netherlands

Stichting Epilepsie Instelling Nederland (SEIN); 🇳🇱 Heemstede, Netherlands

Haga Hospital; 🇳🇱 The Hague, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands