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Longitudinal Monitoring of Cerebral Connectivity 3T MRI in Patients With a Transcient Global Amnesia

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ClinicalTrials.gov Identifier: NCT02796287
Recruitment Status : Terminated (The principal investigator decided to stop the study.)
First Posted : June 10, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

The transient global amnesia (IA) is defined clinically as a temporary suspension and isolated from the ante and retrograde memory, totally regressing within 24 hours. The causes of AI remain unknown. The diagnosis of IA is based on consensus clinical criteria including the absence of associated location marks. In clinical practice, the MRI is often performed in conjunction with clinical examination because it ensures the absence of differential diagnoses, including stroke.

The visualization of MRI signal abnormalities related to AI directly dependent on the completion time of the review in relation to the onset of symptoms. Typically, no signal abnormality is visible in the hyperacute phase (ie D0-D1) while punctate appear hyperintense on diffusion sequences in hippocampal structures from J2 to J7 to disappear completely. It has been previously demonstrated that the use of higher values of b and / or a better spatial resolution significantly increases the sensitivity of the broadcasting sequence for the detection of these abnormalities hippocampal signal. At St. Joseph Hospital, Investigators explore the AI suspected patients with diffusion tensor sequence (DTI) on our high resolution 3T MRI.

Compared to the classical diffusion sequence, DTI is characterized by the use of a greater number of directions in which the diffusion gradients are applied. One advantage of this technique is to be able to perform tractography of white matter fibers. Thus the "connectome" is a new technique for post-processing of DTI images based tractography and to assess all the networks of nerve fibers in the brain. By this technique, the values of average diffusivity (MD) and fractional anisotropy (FA) can be measured along each of the studied nerve fibers. Group studies thus become feasible to compare quantitatively healthy subjects and patients groups in terms of structural differences within the connectome. The contribution of this technique was recently highlighted in patients with temporal lobe epilepsy.


Condition or disease Intervention/treatment Phase
Amnesia Procedure: achieving a neuropsychological examination in the acute amnesic phase Procedure: Neurological consultation with neuropsychological evaluation Radiation: MRI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Longitudinal Monitoring of Cerebral Connectivity 3T MRI in Patients With a Transcient Global Amnesia
Actual Study Start Date : September 2, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

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Arm Intervention/treatment
Experimental: Patients with Ictus amnesic
Patients admitted in the hospital as part of their medical care with amnesic Ictus episode
Procedure: achieving a neuropsychological examination in the acute amnesic phase
achieving a neuropsychological examination in the acute phase in addition to the normal protocole

Procedure: Neurological consultation with neuropsychological evaluation
Neurological consultation with neuropsychological evaluation one year after the acute amnesic phase

Radiation: MRI
Brain MRI with the same protocol or an acquisition time of 15 minutes without gadolinium, one year after the acute amesic phase




Primary Outcome Measures :
  1. Assessment of change of connectivity graphs representative of the FA (fraction anisotropy) facts [ Time Frame: Day 2, 1 year ]
    Comparison of connectivity graphs representing the FA values between the three groups of subjects : normal subjects , patients explored J2, explored patients at 1 year

  2. Assessment of change of connectivity graphs representative of the MD (mean diffusivity) facts [ Time Frame: Day 2, 1 year ]
    Comparison of connectivity graphs representing the MD values between the three groups of subjects : normal subjects , patients explored J2, explored patients at 1 year



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a typical transient global amnesia
  • Sent for MRI as part of usual care protocol

Exclusion Criteria:

  • Any contraindication of MRI
  • Atypical clinical and / or radiological
  • Other active disease of the Central Nervous System
  • Patients with a history of cerebral infarction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796287


Locations
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France
Groupe Hopitalier Paris Saint Joseph Service de radiologie
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Jerome HODEL, MD Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02796287     History of Changes
Other Study ID Numbers: ICTUS
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: August 2018

Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Amnesia
transient global amnesia

Additional relevant MeSH terms:
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Amnesia
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders