Neuropsycholgy and Neuroimaging in Transient Global Amnesia | NCT02562560

Studies
Neuropsycholgy and Neuroimaging in Transient Global Amnesia

NCT02562560

Sponsor

University Hospital, Caen

Status

Terminated

Last Update Posted

Sep 1, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Transient Global Amnesia (TGA)

Interventions

Neuropsychological tests
Cerebral imaging (MRI, PET-FDG)

Countries

Not provided

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no more patient

Expanded Access Info

Start Date

Sep 2008Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 29, 2015Estimated

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

Aug 31, 2020

Last Update Posted Date

Sep 1, 2020Actual

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

The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TGA	Experimental		Behavioral: Neuropsychological tests Device: Cerebral imaging (MRI, PET-FDG)
Controls	Experimental		Behavioral: Neuropsychological tests Device: Cerebral imaging (MRI, PET-FDG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropsychological tests	Behavioral		Controls TGA
Cerebral imaging (MRI, PET-FDG)

Measure	Description	Time Frame
Episodic memory scores		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the participants
- Minimum of 7 years of education
- French native speaker
Healthy subjects : Non pathological Dementia rating scale score
Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion

Exclusion Criteria:

Chronic neurological disease
Encephalitis
Endocrinal disease
Hepatic disease
Case history of head injury with loss of consciousness of more than one hour
Case history of stroke
Case history of cancer during the five last years except squamous cell carcinomas
Alcoholism or drug addiction
Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fausto Viader, PUPH	University Hospital, Caen	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020236	Amnesia, Transient Global

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000647	Amnesia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009483	Neuropsychological Tests

Ancestor Terms

ID	Term
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided