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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transient Global Amnesia (TGA)

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 28, 2015
    Last Updated
    August 31, 2020
    Sponsor
    University Hospital, Caen
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    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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