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

NCT ID: NCT02885207

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-07-31

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.

Conditions

Epilepsy

Keywords

Limbic encephalitis; anti-neuronal antibodies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focal epilepsy of unknown cause

Group Type: OTHER

Focal epilepsy of unknown cause

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BENOILID Aurélien, MD

Role: PRINCIPAL_INVESTIGATOR

not affiliated

Locations

CHU de Besançon

Besançon, , France

Site Status: NOT_YET_RECRUITING

CHU de Dijon

Dijon, , France

Site Status: NOT_YET_RECRUITING

CHU de Nancy

Nancy, , France

Site Status: NOT_YET_RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

BENOILID Aurélien, MD

Role: CONTACT

Phone: 0388128568

Email: aurelienbenoilid@gmail.com

DE SEZE Jérôme, MD

Role: CONTACT

Facility Contacts

BERGER Eric, MD

Role: primary

LEMESLE Matine, MD

Role: primary

MAILLIARD Louis, MD

Role: primary

Other Identifiers

2014-A00785-42

Identifier Type: -

Identifier Source: org_study_id