- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885207
Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed (IBADEPIF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: BENOILID Aurélien, MD
- Phone Number: 0388128568
- Email: aurelienbenoilid@gmail.com
Study Contact Backup
- Name: DE SEZE Jérôme, MD
Study Locations
-
-
-
Besançon, France, 25000
- Not yet recruiting
- CHU de Besançon
-
Contact:
- BERGER Eric, MD
- Phone Number: 03 81 66 81 66
- Email: neurologie-secret@chu-besancon.fr
-
Dijon, France, 21079
- Not yet recruiting
- CHU de DIJON
-
Contact:
- LEMESLE Matine, MD
- Phone Number: 03 80 29 30 31
- Email: martine.lemesle@chu-dijon.fr
-
Nancy, France, 54000
- Not yet recruiting
- CHU de Nancy
-
Contact:
- MAILLIARD Louis, MD
- Phone Number: 03 83 85 16 09
-
Strasbourg, France, 67091
- Recruiting
- Les Hôpitaux Universitaires de Strasbourg
-
Principal Investigator:
- BENOILID Aurélien, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Focal epilepsy of unknown cause
|
Male or female 18-65 years presenting focal epilepsy on the following arguments:
From unknown cause:
Without treatment by benzodiazepines or anti-epileptics first-line monotherapy (excluding benzodiazepines). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: BENOILID Aurélien, MD, Not Affiliated
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00785-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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