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

Epilepsy Clinical Trial

— IBADEPIF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02885207
• Other study ID #: 2014-A00785-42
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2014
• Last updated: August 25, 2016
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Strasbourg, France
• Contact: BENOILID Aurélien, MD
• Phone: 0388128568
• Email: aurelienbenoilid[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU de Dijon	Dijon
France	CHU de Nancy	Nancy
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum analysis:(composite measure)	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	No
Other	CSF analysis (composite measure)	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	No
Primary	anti-neuronal antibodies	Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.	2 years	No
Secondary	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	2 years	No