Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia (SPREAD)

June 20, 2019 updated by: University Hospital, Strasbourg, France
Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

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

Study Locations

  • France
      • Grenoble, France, 38043
      • Lille, France, 59037
      • Lyon, France, 69001
      • Marseille, France, 13005
      • Nancy, France, 54000
        • Recruiting
        • University Hospital of NANCY
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • GH Pitié-Salpêtrière-Charles Foix
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Necker-Enfants Malades Hospital
        • Contact:
      • Paris, France, 75019
        • Recruiting
        • Rothschild Foundation
        • Contact:
      • Rennes, France, 35000
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
        • Recruiting
        • Hopital Pierre Paul Riquet
        • Contact:

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

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult or pediatric (Age more than 2 years old) patients attending tertiary epilepsy center for presurgical evaluation of refractory focal epilepsy compatible with FCD

Description

Inclusion Criteria:

  • Adult or pediatric patient suffering from drug-resistant focal epilepsy;
  • Age more than 2 years old;
  • Brain MRI suggestive of FCD or normal;
  • Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests;
  • Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring;
  • Resective surgery with a minimal post-operative follow-up of 12 months;
  • Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCD type II).
  • Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures.

Exclusion Criteria:

  • Brain MRI suggestive of another type of lesion;
  • Difficulty to read or understand French, or inability to understand the information;
  • Pregnant or breastfeeding woman;
  • Subject under judicial protection.
  • Other lesion discovered on histological examination;
  • FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings
  • Lack of longitudinal pre- and post-surgical follow-up.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The SEEG group
Group with the SEEG analysis
Procedure: visual and quantitative SEEG signal analysis
signal SEEG analysis
Procedure: Resective epilepsy surgery procedure
Surgical removal of the epileptogenic brain area
The direct surgery group
Group with a direct surgery
Procedure: Resective epilepsy surgery procedure
Surgical removal of the epileptogenic brain area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of each of six seizure-onset pattern types within each of three histologically defined subgroups (FCD type I, FCD type II, non-pathologic findings).
Time Frame: 12 month
12 month
Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)
Time Frame: 12 month
12 month
Topographic distribution of structures that disclose high Epileptogenicity Index values (EI>0.4), of structures with maximal interictal HFO rates and of structures showing interictal/preictal functional connectivity alterations
Time Frame: 12 month
12 month

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (ACTUAL)

January 15, 2018

Primary Completion (ANTICIPATED)

December 15, 2022

Study Completion (ANTICIPATED)

December 15, 2022

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6647

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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