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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04871555
Other study ID # 2020PI218
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2021
Source Central Hospital, Nancy, France
Contact Louise Tyvaert, Pr
Phone 33383857723
Email l.tyvaert@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 115
Est. completion date December 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
MRI
structural imaging

Locations

Country Name City State
France Central Hospital nancy Nancy

Sponsors (4)

Lead Sponsor Collaborator
Central Hospital, Nancy, France Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Hospices Civils de Lyon, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation structural cartography and electroclinical data correlation between patterns of insular structural connectivity and subtypes of epilepsy defined by electroclinical data 1 year after the last inclusion
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