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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Focal epilepsy of unknown cause
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Limbic encephalitis, anti-neuronal antibodies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Besançon
  • CHU de Dijon
  • CHU de Nancy
  • Les Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Focal epilepsy of unknown cause

Arm Description

Outcomes

Primary Outcome Measures

anti-neuronal antibodies
Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.

Secondary Outcome Measures

statistically significant differences between people with and without-neuronal antibodies differences
Related to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated

Full Information

First Posted
October 9, 2014
Last Updated
August 25, 2016
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02885207
Brief Title
Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
Acronym
IBADEPIF
Official Title
Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Limbic encephalitis, anti-neuronal antibodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focal epilepsy of unknown cause
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Focal epilepsy of unknown cause
Intervention Description
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 Measure Information:
Title
anti-neuronal antibodies
Description
Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
statistically significant differences between people with and without-neuronal antibodies differences
Description
Related to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Serum analysis:(composite measure)
Description
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
Time Frame
2 years
Title
CSF analysis (composite measure)
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BENOILID Aurélien, MD
Phone
0388128568
Email
aurelienbenoilid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DE SEZE Jérôme, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BENOILID Aurélien, MD
Organizational Affiliation
not affiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BERGER Eric, MD
Phone
03 81 66 81 66
Email
neurologie-secret@chu-besancon.fr
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEMESLE Matine, MD
Phone
03 80 29 30 31
Email
martine.lemesle@chu-dijon.fr
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAILLIARD Louis, MD
Phone
03 83 85 16 09
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BENOILID Aurélien, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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