Clinical Trial: Antibodies Causing Epilepsy Syndromes: The ACES Study.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Antibodies Causing Epilepsy Syndromes: The ACES Study.

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 Summary: 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.
Sponsor: Erasmus Medical Center

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Erasmus Medical Center

Dates:
Date Received: June 7, 2016
Date Started: December 2014
Date Completion: July 2018
Last Updated: June 13, 2016
Last Verified: June 2016