Discard the Curative Causes of Late Onset Epilepsy: the R... | NCT05831371

Studies
Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET

NCT05831371

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Apr 26, 2023Actual

Enrollment

87Estimated

Phase

Not provided

Conditions

Late Onset Epilepsy
Alzheimer Disease

Interventions

TEP FDG

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2023Estimated

Primary Completion Date

Aug 2, 2023Estimated

Completion Date

Sep 2, 2023Estimated

First Submitted Date

Apr 14, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

Apr 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Estimated

Name	Type	Description	Arm Group Labels	Other Names
TEP FDG	Diagnostic Test	FDG TEP peformed in clinical routine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic performances	sensibility, specificty, accurracy	2 years after epilepsy onset

Secondary Outcomes

Measure	Description	Time Frame
cognitive prognosis performances	sensibility, specificty, accurracy	2 years after epilepsy onset

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

late onset épilepsy patients without lesion
epilepsy followed at the CHRU Nancy france

Exclusion Criteria:

epilepsy explained by cortical lesion
severe psychiatric disorders
severe addiction (alcool, drugs)
no FDG TEP performed
no neuropsychological assessement after 2 years epilepsy onset

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

non lesional late onset epilepsy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy		Nancy		54000	France	Louise TYVAERT

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided