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Completed

NCT Number: NCT02802475

Antibodies Causing Epilepsy Syndromes: The ACES Study.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vena punction

Biological

Primary outcomes

  1. 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

Secondary outcomes

  1. modified Rankin scale

    Time frame: 1 year

    outcome 1 year after inclusion in the study

  2. Seizure frequency

    Time frame: 1 year

    seizure frequency 1 year after inclusion in the study

  3. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Nationaal Epilepsie Fonds

Registry information

Acronym: ACES

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jun 16, 2016
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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