Transient Global Amnesia (TGA). Exploratory Study of the Default Mode Network During the Acute Phase

NCT02010853 | Completed DMC

• 2 other identifiers: 13 201 022013-A01271-44
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The transient global amnesia, in which the memory disorder is massive, transient and pure, offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and selective lesion located on the CA1 region of the hippocampus better visible between 48h and 72h after onset of the episode. There is therefore a real dissociation between structural lesions witch are minimal or non-existent and the massive memory disorder. This suggests that functional impairment goes far beyond the structural damage in this condition. To our knowledge, no study has been performed to identify this functional impairment using resting state fMRI. Thus, investigators wish to study the neural networks involved in memory impairment during the acute phase of transient global amnesia using resting state imaging. This technique appears to be modern and adapted to these patients population. Investigators hypothesize that despite limited structural lesions, a large functional network is impaired compared to that observed in a group of healthy subjects. investigators believe that the alteration of the functional network will explain the depth of memory impairment observed. The main aim of this study will be to identify functional impairment in the patient group vs. control group during the acute phase of transient global amnesia (TGA) using resting state imaging. Patients potentially eligible will be informed during their arrival to the emergency unit. If the patient is eligible and would like to participate, information will be given. For the patients willing to participate, inclusion and exclusion criteria will be verified. Two imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment will be performed during three visits.

Conditions

Amnesia

Keywords

Transient Global amnesia; fMRI; resting state

Outcome Measures

Primary Outcomes (1)

• The primary judgment criteria will be the difference in activation probabilistic resting state maps between patient and control groups during the acute phase.

  3 months

Secondary Outcomes (1)

• memory performance tests and functional activity

  3 months

Study Arms (2)

patient

EXPERIMENTAL

each patient TGA will receive an evaluation in resting state IRMf during three successive visits: * During the acute phase within 24 hours * In 72 hours * In 3 months

Other: IRMf

control

OTHER

each control will receive an evaluation in resting state IRMf during three successive visits: * During the acute phase within 24 hours * In 72 hours * In 3 months

Other: IRMf

Interventions

IRMf OTHER

evaluation in resting state fMRI during three successive visits: * During the acute phase within 24 hours * In 72 hours * In 3 months

control; patient

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient group
• Clinical criteria of definition of transient global amnesia:

You may not qualify if:

• Hippocampal lesion in DWI MRI performed at 72h Clinical resolution of memory disorder within 24 hours
• Control group No cognitive complaint No history of transient amnesia
• Both groups Age between 40 and 80 years old
• Patient group Disturbance of consciousness or loss of identity Argument in favor of seizure disorders Presence of a neurological deficit focused
• Both groups Recent head trauma Acute intoxication ethyl Taking drugs influencing memory processing Severe hypoglycemia Psychiatric disorder altering capacity for judgment Progressive neurological disorder with cognitive alteration Indication against MRI French language level insufficient to be appropriately involved in neuropsychological assessment, Administrative issues: unable to give informed about information, not covered by a social security system, refusal to sign the consent, patient under curators.
• Pregnant Woman

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Chu Purpan

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Amnesia; Amnesia, Transient Global

Condition Hierarchy (Ancestors)

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• PrJérémie Pariente, PHD

  Department of Neurology, Purpan Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)