Structural Cartography of the Insula in Temporal Epilepsy Patients
CON-INSULA
1 other identifier
observational
115
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 4, 2021
April 1, 2021
11 months
April 29, 2021
April 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cartography of insula in temporal epilepsy patients
Compared with healthy group, definition of different patterns of insular structural connectivity in epileptic patients
1 year after the last inclusion
Secondary Outcomes (1)
Correlation structural cartography and electroclinical data
1 year after the last inclusion
Study Arms (6)
mesio-temporal epilepsy
patients suffering from mesiotemporal epilepsy type
basal temporal epilepsy
patients suffering from basal temporal epilepsy type
temporal lateral epilepsy
patients suffering from temporal lateral epilepsy type
operculo insular epilepsy
patients suffering from operculo insular epilepsy type
temporo-insular epilepsy
patients suffering from temporo- insular epilepsy type
healthy subjects
non epileptic patients
Interventions
structural imaging
Eligibility Criteria
temporal epilepsy patients and healthy subjects healthy subjects will be selected in the healthy cohort of Nguyen G-Dang (Ghaziri et al., 2017)
You may qualify if:
- 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
You may not qualify if:
- patients younger than 15 years old
- patients with previous brain surgery (before MRI)
- uncompleted MRI sequences (DTI, T1 anatomical)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- Centre de Recherche du Centre Hospitalier de l'Université de Montréalcollaborator
- University Hospital, Lillecollaborator
- Hospices Civils de Lyoncollaborator
Study Sites (1)
Central Hospital nancy
Nancy, 54000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Tyvaert, MD PHD
CHRU Nancy, CRAN UMR 7039 Université de Lorraine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 4, 2021
Study Start
June 1, 2021
Primary Completion
April 30, 2022
Study Completion
December 31, 2022
Last Updated
May 4, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share