Investigation of Human Epileptic Networks by fMRI

Summary

Background:

In the Emilia-Romagna Region approximately 19.000 people are affected by epilepsy. About 25% of epileptic patients are drug-resistant (DRE) and some of them are eligible for resective surgery of the epileptogenic zone (EZ). The precise EZ localization is crucial for a good surgical outcome. Intracranial EEG (icEEG) recordings remain the gold-standard to localise the EZ. New neuroimaging techniques, like simultaneous recording of functional MRI and EEG (EEG-fMRI), with advanced methodological approaches as effective connectivity analysis (i.e. Dynamic Causal Modelling-DCM) might improve the EZ localization.

Objectives:

(1) To develop a non-invasive protocol for the investigation of the epileptic network in patients with surgically remediable epilepsies; (2) To shed light on the patho-physiological mechanisms of drug resistance in DRE; (3) To provide a validation of effective connectivity applied to fMRI data in epilepsy.

Methods:

Two Research Units (RU1, RU2) will identify and characterize a cohort of DRE patients eligible for resective surgery. RU1 will be in charge to perform the EEG/fMRI coregistration and data analysis. RU2 will be responsible for the surgical resection of epileptic foci. IcEEG recordings will be performed at the Claudio Munari Epilepsy Center, Ospedale Niguarda, Milano. RU1\&RU2 will evaluate the fMRI data results and compare with icEEG findings or expert's surgical decision. The principle measures of outcome are: (a) percentage of concordance of fMRI results with icEEG findings or electro-clinical features in term epileptic network identification; (b) percentage of concordance between DCM findings and EZ/IZ localization; (c) percentage of concordance of DCM findings with icEEG or electro-clinical features regarding the causal hierarchy within the epileptic network.

Conditions

• Epilepsy

Interventions

PROCEDURE

EEG/fMRI

All the patients recruited will undergo to the following interventions: 1\. Presurgical assesment protocol of the recruited patients (RU1 and RU2) that will includes: (a) detailed medical and epilepsy patients' history; (b) neurologic evaluation; (c) structural 3 Tesla MRI; (d) prolonged video-EEG monitoring including one-overnight EEG recording; (e) neuropsychological evaluation including quality of life evaluation. 2. EEG-fMRI coregistration: All subjects will undergo to a Video-EEG/fMRI study. This protocol will include a 32-channels EEG recorded simultaneously to fMRI data acquisition (3T scanner, Philips). This phase will be articulated in two steps: (i) acquisition of the EEG-fMRI data; (ii) fMRI data analysis (conventional and DCM analysis). RU1 will be charged for both steps. 3. Surgical resection of the epileptic foci and/or intracranial electrode recording (icEEG). The DRE patients in whom an intracranial recording will be considered unnecessary, will be operated at the RU2.

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna

  collaborator OTHER

• Azienda Unita' Sanitaria Locale Di Modena

  lead OTHER

Principal Investigators

• Anna Elisabetta Vaudano, MD · Azienda Unita' Sanitaria Modena

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-02

Primary Completion

2017-01-01

Completion

2018-01-01