Neuropsycholgy and Neuroimaging in Transient Global Amnesia (2NIA)
Primary Purpose
Transient Global Amnesia (TGA)
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuropsychological tests
Cerebral imaging (MRI, PET-FDG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Transient Global Amnesia (TGA)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TGA
Controls
Arm Description
Outcomes
Primary Outcome Measures
Episodic memory scores
Secondary Outcome Measures
Full Information
NCT ID
NCT02562560
First Posted
September 28, 2015
Last Updated
August 31, 2020
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02562560
Brief Title
Neuropsycholgy and Neuroimaging in Transient Global Amnesia
Acronym
2NIA
Official Title
Neuropsycholgy and Neuroimaging in Transient Global Amnesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
no more patient
Study Start Date
September 2008 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Global Amnesia (TGA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TGA
Arm Type
Experimental
Arm Title
Controls
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological tests
Intervention Type
Device
Intervention Name(s)
Cerebral imaging (MRI, PET-FDG)
Primary Outcome Measure Information:
Title
Episodic memory scores
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto Viader, PUPH
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Neuropsycholgy and Neuroimaging in Transient Global Amnesia
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