Structural Cartography of the Insula in Temporal Epilepsy Patients (CON-INSULA)

April 29, 2021 updated by: TYVAERT Louise, Central Hospital, Nancy, France
The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

Study Type

Observational

Enrollment (Anticipated)

115

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Nancy, France, 54000
        • Central Hospital Nancy

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

temporal epilepsy patients and healthy subjects

healthy subjects will be selected in the healthy cohort of Nguyen G-Dang (Ghaziri et al., 2017)

Description

Inclusion Criteria:

  • epileptic patients: temporal epilepsy or temporal plus epilepsy (temporomesial epilepsy, basal temporal epilepsy, mesio lateral or lateral epilepsy, temporo insular epilepsy, operculo insular epilepsy)
  • patients who underwent video EEG monitoring with recorded seizures (at least one)
  • patients who underwent a brain MRI with DTI sequence before epilepsy surgery
  • patients who did not refuse the use of their clinical and MRI data for this study

Exclusion Criteria:

  • patients younger than 15 years old
  • patients with previous brain surgery (before MRI)
  • uncompleted MRI sequences (DTI, T1 anatomical)

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
mesio-temporal epilepsy
patients suffering from mesiotemporal epilepsy type
Other: MRI
structural imaging
basal temporal epilepsy
patients suffering from basal temporal epilepsy type
Other: MRI
structural imaging
temporal lateral epilepsy
patients suffering from temporal lateral epilepsy type
Other: MRI
structural imaging
operculo insular epilepsy
patients suffering from operculo insular epilepsy type
Other: MRI
structural imaging
temporo-insular epilepsy
patients suffering from temporo- insular epilepsy type
Other: MRI
structural imaging
healthy subjects
non epileptic patients
Other: MRI
structural imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cartography of insula in temporal epilepsy patients
Time Frame: 1 year after the last inclusion
Compared with healthy group, definition of different patterns of insular structural connectivity in epileptic patients
1 year after the last inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation structural cartography and electroclinical data
Time Frame: 1 year after the last inclusion
correlation between patterns of insular structural connectivity and subtypes of epilepsy defined by electroclinical data
1 year after the last inclusion

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Collaborators

Hospices Civils de Lyon
University Hospital, Lille
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

  • Principal Investigator: Louise Tyvaert, MD PHD, CHRU Nancy, CRAN UMR 7039 Université de Lorraine

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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