Localizing the Epileptogenic Zone With High Resolution Electroencephalography

NCT ID: NCT01090934

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Partial Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high resolution EEG

Group Type EXPERIMENTAL

High Resolution EEG

Intervention Type DEVICE

High Resolution EEG

Stereo Electroencephalography

Group Type ACTIVE_COMPARATOR

Stereo-electroencephalography

Intervention Type DEVICE

SEEG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Resolution EEG

High Resolution EEG

Intervention Type DEVICE

Stereo-electroencephalography

SEEG

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

electrical source imaging depth-electroencephalography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
* Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
* full informed consent of the patient (or of his/ her legal representative)
* 15 year or older patient

Exclusion Criteria

* contraindication to cortectomy
* contraindication to depth-EEG
* indication of epilepsy surgery without depth-EEG monitoring
* high grade glioma, arterio-veinous malformations

* pregnancy
* history of severe cardio-vascular event (coronaropathy, stroke)
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Marseille

OTHER

Sponsor Role collaborator

CHU de Reims

OTHER

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

louis maillard

Dr Louis MAILLARD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis Maillard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Marseille

Marseille, , France

Site Status

Central Hospital

Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.

Reference Type BACKGROUND
PMID: 19632148 (View on PubMed)

Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.

Reference Type BACKGROUND
PMID: 20206700 (View on PubMed)

Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.

Reference Type RESULT
PMID: 21140291 (View on PubMed)

Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.

Reference Type RESULT
PMID: 21095980 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-A00574-53

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Localizing Epileptic Networks Using MRI and iEEG
NCT04649008 RECRUITING EARLY_PHASE1