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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03321240
• Collaborator: (none)
• Enrollment: 240
• Locations: 11
• Anticipated Duration (Months): 59
• Patients Per Site: 21.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Epilepsy; Focal Epilepsy; Focal Cortical Dysplasia	Procedure: visual and quantitative SEEG signal analysis; Procedure: Resective epilepsy surgery procedure

Study Design

• Study Type: Observational
• Anticipated Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
• Actual Study Start Date: Jan 15, 2018
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery. [12 month]

Secondary Outcome Measures

1. 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). [12 month]

2. Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI) [12 month]

3. 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 [12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michallon Hospital	Grenoble		France	38043
2	Hôpital Roger Salengro	Lille		France	59037
3	Hospices Civils de Lyon	Lyon		France	69001
4	Timone Hospital	Marseille		France	13005
5	University Hospital of Nancy	Nancy		France	54000
6	GH Pitie-Salpêtrière-Charles Foix	Paris		France	75013
7	Necker-Enfants Malades Hospital	Paris		France	75015
8	Rothschild Foundation	Paris		France	75019
9	CHU Rennes	Rennes		France	35000
10	Les Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091
11	Hôpital Pierre Paul Riquet	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT03321240
• Other Study ID Numbers: 6647
• First Posted: Oct 25, 2017
• Last Update Posted: Jun 24, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: focal cortical dysplasia; Pronostic; Epilepsy surgery; Epiletogenicity index; SEEG
• Additional relevant MeSH terms: Epilepsy; Drug Resistant Epilepsy; Epilepsies, Partial; Malformations of Cortical Development; Hyperplasia

Study Results

No Results Posted as of Jun 24, 2019