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

August 25, 2016 updated by: University Hospital, Strasbourg, France

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

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: DE SEZE Jérôme, MD

Study Locations

      • Besançon, France, 25000
      • Dijon, France, 21079
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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).

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: BENOILID Aurélien, MD, Not Affiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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