NCT03582345

Investigation of Human Epileptic Networks by fMRI

Completed NA Last updated 12 July 2018

What this trial tests

NA trial testing EEG/fMRI in Epilepsy in 35 participants. Completed in 1 January 2018.

Timeline

2 January 2015

Primary endpoint
1 January 2017

1 January 2018

Quick facts

Lead sponsor	Azienda Unita' Sanitaria Locale Di Modena
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	35
Start date	2 January 2015
Primary completion	1 January 2017
Estimated completion	1 January 2018

Drugs / interventions tested

• EEG/fMRI

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Who can join

Adults 18 to 75, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.