Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02885207
Acronym
IBADEPIF
Enrollment
200
Registered
2016-08-31
Start date
2015-06-30
Completion date
2017-07-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Limbic encephalitis, anti-neuronal antibodies

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.

Interventions

BIOLOGICALFocal 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).

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
anti-neuronal antibodies2 yearsIncidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.

Secondary

MeasureTime frameDescription
statistically significant differences between people with and without-neuronal antibodies differences2 yearsRelated to population characteristics: age, sex, ethnicity, handedness, immune dysfunction associated field, psychiatric field associated migraine associated

Other

MeasureTime frameDescription
Serum analysis:(composite measure)2 yearsDirected 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
CSF analysis (composite measure)2 yearsA 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

Countries

France

Contacts

Primary ContactBENOILID Aurélien, MD
aurelienbenoilid@gmail.com0388128568
Backup ContactDE SEZE Jérôme, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026