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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02010853
First received: December 4, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Amnesia
Other: IRMf

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • The primary judgment criteria will be the difference in activation probabilistic resting state maps between patient and control groups during the acute phase. [ Time Frame: 3 mounth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • memory performance tests and functional activity [ Time Frame: 3 mounths ] [ Designated as safety issue: Yes ]
    The correlation coefficient between memory performance tests and functional activity observed in resting state fMRI in the group of patients.


Estimated Enrollment: 44
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient

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

evaluation in resting state fMRI during three successive visits:

  • During the acute phase within 24 hours
  • In 72 hours
  • In 3 months
control

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

evaluation in resting state fMRI during three successive visits:

  • During the acute phase within 24 hours
  • In 72 hours
  • In 3 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient group

Clinical criteria of definition of transient global amnesia:

Acute disorder of anterograde memory observed by a witness. Respect of the other cognitive functions. No exclusion criteria for this diagnosis (see exclusion criteria section).

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010853

Contacts
Contact: Jérémie PARIENTE, PU-PH 05-61-77-76-86 jeremie.pariente@inserm.fr
Contact: Emilie RIGAL, Resident 06-16-23-48-45 emilyxvx@hotmail.com

Locations
France
Chu Purpan Recruiting
Toulouse, France, 31000
Contact: Jeremie Pariente, PHD         
Principal Investigator: Jeremie Pariente, PHD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: PrJérémie Pariente, PHD Department of Neurology, Purpan Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02010853     History of Changes
Other Study ID Numbers: 13 201 02, 2013-A01271-44
Study First Received: December 4, 2013
Last Updated: August 28, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
Transient Global amnesia
fMRI
resting state

Additional relevant MeSH terms:
Amnesia
Amnesia, Transient Global
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014