NCT02562560

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 1, 2020

Status Verified

November 1, 2015

Enrollment Period

6.8 years

First QC Date

September 28, 2015

Last Update Submit

August 31, 2020

Conditions

Transient Global Amnesia (TGA)

Outcome Measures

Primary Outcomes (1)

  • Episodic memory scores

    3 years

Study Arms (2)

TGA

EXPERIMENTAL
Behavioral: Neuropsychological testsDevice: Cerebral imaging (MRI, PET-FDG)

Controls

EXPERIMENTAL
Behavioral: Neuropsychological testsDevice: Cerebral imaging (MRI, PET-FDG)

Interventions

Neuropsychological testsBEHAVIORAL
ControlsTGA
Cerebral imaging (MRI, PET-FDG)DEVICE
ControlsTGA

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amnesia, Transient Global

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmnesiaMemory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Fausto Viader, PUPH

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 29, 2015

Study Start

September 1, 2008

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

September 1, 2020

Record last verified: 2015-11