NCT04871555

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 29, 2021

Last Update Submit

April 29, 2021

Conditions

Keywords

structural connectivityinsulatemporal lobe epilepsy

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

Other: MRI

basal temporal epilepsy

patients suffering from basal temporal epilepsy type

Other: MRI

temporal lateral epilepsy

patients suffering from temporal lateral epilepsy type

Other: MRI

operculo insular epilepsy

patients suffering from operculo insular epilepsy type

Other: MRI

temporo-insular epilepsy

patients suffering from temporo- insular epilepsy type

Other: MRI

healthy subjects

non epileptic patients

Other: MRI

Interventions

MRIOTHER

structural imaging

basal temporal epilepsyhealthy subjectsmesio-temporal epilepsyoperculo insular epilepsytemporal lateral epilepsytemporo-insular epilepsy

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

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

Study Sites (1)

Central Hospital nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Officials

  • Louise Tyvaert, MD PHD

    CHRU Nancy, CRAN UMR 7039 Université de Lorraine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Tyvaert, Pr

CONTACT

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

Locations