Antibodies Causing Epilepsy Syndromes: The ACES Study. (ACES)

July 27, 2022 updated by: M.J. Titulaer, Erasmus Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

582

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Heemstede, Netherlands
        • Epilepsiecentrum Kempenhaeghe
      • Heemstede, Netherlands
        • Stichting Epilepsie Instelling Nederland (SEIN)
      • Maastricht, Netherlands
        • Academic Hospital Maastricht
      • Rotterdam, Netherlands
        • Maasstad Hospital
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
      • The Hague, Netherlands
        • Haga Hospital
      • Tilburg, Netherlands
        • St. Elisabeth Hospital
      • Utrecht, Netherlands
        • UMCU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of patients with known and novel antibodies
Time Frame: 3 year
detection of specific known and novel, currently unknown, auto-antibodies by immunohistochemistry, live hippocampal neuron cultures and cell-based assay
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin scale
Time Frame: 1 year
outcome 1 year after inclusion in the study
1 year
Seizure frequency
Time Frame: 1 year
seizure frequency 1 year after inclusion in the study
1 year
Treatment response
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Nationaal Epilepsie Fonds

Investigators

  • Principal Investigator: Maarten J Titulaer, MD,PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 2014-463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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