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Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed (IBADEPIF)

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ClinicalTrials.gov Identifier: NCT02885207
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.

The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.

The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.


Condition or disease Intervention/treatment Phase
Epilepsy Biological: Focal epilepsy of unknown cause Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
Study Start Date : June 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Focal epilepsy of unknown cause Biological: Focal epilepsy of unknown cause

Male or female 18-65 years presenting focal epilepsy on the following arguments:

  • Crisis with clinical symptoms indicating focal seizure
  • & / Or crisis or critical focal inter-recorded EEG interpreted by a neurologist with expertise in the field of epilepsy.

From unknown cause:

  • No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
  • No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
  • No argument for metabolic or neurodegenerative genetic epilepsy.
  • Normal neurological examination. Epilepsy that started within a maximum period of 2 years prior to inclusion in the study (including vegetative symptoms of temporal focal seizures).

Without treatment by benzodiazepines or anti-epileptics first-line monotherapy (excluding benzodiazepines).





Primary Outcome Measures :
  1. anti-neuronal antibodies [ Time Frame: 2 years ]
    Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.


Secondary Outcome Measures :
  1. statistically significant differences between people with and without-neuronal antibodies differences [ Time Frame: 2 years ]
    Related to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated


Other Outcome Measures:
  1. Serum analysis:(composite measure) [ Time Frame: 2 years ]
    Directed by a blood test on a peripheral vein: ANA, anti-ENA, anti-DNA, ANCA, anti-TPO, anti-TGO, APL, anti-GAD, anti-transglutaminase / anti-Hu, Yo, Ri, CV2 , amphiphysin, Ma2 / VGKC complex, anti-NMDA-R, anti-AMPA-R, anti-GABA B-R / Other: NFS, CRP, ESR, TSH, PT, APTT

  2. CSF analysis (composite measure) [ Time Frame: 2 years ]
    A lumbar puncture is performed under strict aseptic conditions, in the absence cons classic indications (abnormal crushes or platelet count) in hospital, followed by monitoring at least three hours, looking for: ac neurons anti / Finding an oligoclonal distribution (DOC, immunoglobulin synthesis intrathéquale) / WBC and red blood cells, protein level



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18-65 years
  • Presenting focal epilepsy on the following arguments

    • Crisis with clinical symptoms indicating focal seizure
    • & / Or crisis or critical focal inter-recorded on EEG interpreted by a neurologist with expertise in the field of epilepsy.
  • Having not yet received a CSF analysis
  • From unknown cause:

    • No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
    • No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
    • No argument for metabolic or neurodegenerative genetic epilepsy.
    • Normal neurological examination.
  • Epilepsy that started within a period of two years preceding the study entry (including vegetative symptoms of temporal focal seizures).
  • Without treatment or as benzodiazepines or taking anti-epileptic first-line monotherapy (excluding benzodiazepines).
  • Informed consent signed
  • affiliated with a social security scheme

Exclusion Criteria:

  • structural abnormality found in brain MRI (except temporal hyperintensity and / or sclerosis of the hippocampus).
  • Background Neurological: hyperthermic seizures in childhood, neonatal distress, history of seizures related to a circumstance, inflammation or infection of the CNS.
  • Taking toxic: chronic alcoholism, narcotic consumption
  • The case for a genetic / metabolic neurodeg ear /: generalized EEG / photosensitivity / family history of epilepsy / autism / disorder syndrome psychomotor development / dysmorphic syndrome / extrapyramidal syndrome associated discharge
  • History of thyroiditis or m. system (LEAD, SGS, PR, Sarcoidosis)
  • Immunosuppression innate or acquired
  • IC lumbar puncture or have already received a lumbar puncture before inclusion in the protocol.
  • Person under supervision or guardianship.

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): NCT02885207


Contacts
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Contact: BENOILID Aurélien, MD 0388128568 aurelienbenoilid@gmail.com
Contact: DE SEZE Jérôme, MD

Locations
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France
CHU de Besançon Not yet recruiting
Besançon, France, 25000
Contact: BERGER Eric, MD    03 81 66 81 66    neurologie-secret@chu-besancon.fr   
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: LEMESLE Matine, MD    03 80 29 30 31    martine.lemesle@chu-dijon.fr   
CHU de Nancy Not yet recruiting
Nancy, France, 54000
Contact: MAILLIARD Louis, MD    03 83 85 16 09      
Les Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Principal Investigator: BENOILID Aurélien, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: BENOILID Aurélien, MD not affiliated

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02885207     History of Changes
Other Study ID Numbers: 2014-A00785-42
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
Limbic encephalitis
anti-neuronal antibodies

Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases