Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

Epilepsy Clinical Trial

— EPINE  

Official title:

Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455047
• Other study ID #: 2021PI190
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ .

Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years to 56 Years

Eligibility

Inclusion Criteria:

• Patients with drug-resistant temporal epilepsy with an accurate diagnosis on SEEG

• Patients with epilepsy who have had a PET/CT scan with 18F-FDG as part of a pre-operative assessment

• Person having received complete information on the organization of the research and not having objected to the use of these data;

• Patients affiliated to a social security system

Exclusion Criteria:

• Person who has not received full information on the organization of the research and who has opposed the use of this data

• A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice).

• A person of full age who is unable to give consent and who is not subject to a legal protection measure

Related Conditions & MeSH terms

• Epilepsy

Intervention

Diagnostic Test:
• PET-CT at 18F-FDG
PET-CT at 18f6FDG in nuclear medicine departement of Nancy's hospital

Locations

Country	Name	City	State
France	Nancy's Hospital	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic connectivity	Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory	1 month