CClinicalTrials.gg
Status unknownNCT04871555CON-INSULAUpdated May 4, 2021

Structural Cartography of the Insula in Temporal Epilepsy Patients

An observational study in Epilepsy, Temporal Lobe and MRI Scans, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
115
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epilepsy, Temporal Lobe
  • MRI Scans

Keywords

  • structural connectivity
  • insula
  • temporal lobe epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 115 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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)

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

Exclusion Criteria:

  • patients younger than 15 years old
  • patients with previous brain surgery (before MRI)
  • uncompleted MRI sequences (DTI, T1 anatomical)
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
115 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMRI

    structural imaging

06

What researchers measure

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

    Time frame: 1 year after the last inclusion

Secondary outcomes

  1. Correlation structural cartography and electroclinical data

    correlation between patterns of insular structural connectivity and subtypes of epilepsy defined by electroclinical data

    Time frame: 1 year after the last inclusion

07

Study locations

1 site
  • Central Hospital nancy
    Nancy, 54000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04871555
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, University Hospital, Lille, Hospices Civils de Lyon
Responsible party
TYVAERT Louise (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
May 4, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Apr 30, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 4, 2021

Study contacts

Louise Tyvaert, Pr
Contact
l.tyvaert@chru-nancy.fr
33383857723
Louise Tyvaert, MD PHD
principal investigator · CHRU Nancy, CRAN UMR 7039 Université de Lorraine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion