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

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ClinicalTrials.gov Identifier: NCT02802475
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Nationaal Epilepsie Fonds
Information provided by (Responsible Party):
M.J. Titulaer, 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.

Condition or disease Intervention/treatment
Auto-immune Encephalitis Epilepsy Biological: vena punction

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibodies Causing Epilepsy Syndromes: The ACES Study.
Study Start Date : December 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
serum and (if available) CSF


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802475


Contacts
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Contact: Marienke AA de Bruijn, MD 0031628306007 aces@erasmusmc.nl
Contact: Maarten J Titulaer, MD, PhD 0031628306007 aces@erasmusmc.nl

Locations
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Netherlands
Epilepsiecentrum Kempenhaeghe Recruiting
Heemstede, Netherlands
Contact: H JM Majoie       majoiem@kempenhaeghe.nl   
Stichting Epilepsie Instelling Nederland (SEIN) Recruiting
Heemstede, Netherlands
Contact: R D Thijs       rthijs@sein.nl   
Academic Hospital Maastricht Recruiting
Maastricht, Netherlands
Contact: R Rouhl       r.rouhl@mumc.nl   
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands
Contact: M AA de Bruijn       aces@erasmusmc.nl   
Contact: M J Titulaer       aces@erasmusmc.nl   
Maasstad Hospital Recruiting
Rotterdam, Netherlands
Contact: C A van Donselaar       donselaarc@maasstadziekenhuis.nl   
Haga Hospital Recruiting
The Hague, Netherlands
Contact: P W Wirtz       p.wirtz@hagaziekenhuis.nl   
St. Elisabeth Hospital Recruiting
Tilburg, Netherlands
Contact: J TH van Asseldonk       t.v.asseldonk@elisabeth.nl   
UMCU Recruiting
Utrecht, Netherlands
Contact: Leijten, Prof         
Sponsors and Collaborators
Erasmus Medical Center
Nationaal Epilepsie Fonds
Investigators
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Principal Investigator: Maarten J Titulaer, MD,PhD Erasmus Medical Center

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Responsible Party: M.J. Titulaer, MD. PhD., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02802475     History of Changes
Other Study ID Numbers: MEC 2014-463
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Keywords provided by M.J. Titulaer, Erasmus Medical Center:
antibodies
auto-immune encephalitis
epilepsy
limbic encephalitis

Additional relevant MeSH terms:
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Epilepsy
Epileptic Syndromes
Encephalitis
Hashimoto Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs