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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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Epilepsiecentrum Kempenhaeghe, Heemstede, Netherlands
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
Primary outcomes
-
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
-
modified Rankin scale
Time frame: 1 year
outcome 1 year after inclusion in the study
-
Seizure frequency
Time frame: 1 year
seizure frequency 1 year after inclusion in the study
-
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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