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

NCT02796287 | Terminated DMC

• 1 other identifier: ICTUS
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Amnesia

Keywords

Amnesia; transient global amnesia

Outcome Measures

Primary Outcomes (2)

• Assessment of change of connectivity graphs representative of the FA (fraction anisotropy) facts

  Comparison of connectivity graphs representing the FA values between the three groups of subjects : normal subjects , patients explored J2, explored patients at 1 year

  Day 2, 1 year

• Assessment of change of connectivity graphs representative of the MD (mean diffusivity) facts

  Comparison of connectivity graphs representing the MD values between the three groups of subjects : normal subjects , patients explored J2, explored patients at 1 year

  Day 2, 1 year

Study Arms (1)

Patients with Ictus amnesic

EXPERIMENTAL

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; Procedure: Neurological consultation with neuropsychological evaluation; Radiation: MRI

Interventions

achieving a neuropsychological examination in the acute amnesic phase PROCEDURE

achieving a neuropsychological examination in the acute phase in addition to the normal protocole

Patients with Ictus amnesic

Neurological consultation with neuropsychological evaluation PROCEDURE

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

Patients with Ictus amnesic

MRI RADIATION

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

Patients with Ictus amnesic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hopitalier Paris Saint Joseph Service de radiologie

Paris, Île-de-France Region, 75014, 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

• Jerome HODEL, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 10, 2016
• Study Start: September 2, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 15, 2019

Record last verified: 2018-08

Locations

FR (1)