An interventional study of achieving a neuropsychological examination in the acute amnesic phase and Neurological consultation with neuropsychological evaluation in Amnesia, sponsored by Fondation Hôpital Saint-Joseph. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Basic science
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.
/ OBJECTIVES
The main objective of our study is, using the DTI realized 3T to:
1.1 Main Objective
1.2 Secondary Objectives
1.3 Methodology
DESIGN: biomedical, prospective single-center on topics of AI episode as part of their medical care within the hospital group Paris Saint-Joseph, 185 Rue Raymond Losserand 75014 Paris.
Study duration: 2 years from May 2015 in the rate of inclusion estimated to average 2-3 patients per month (ie inclusion period of one year: from May 2015 to May 2016 and last follow-up in May 2017 ).
start and end dates: May 2015 to May 2017 Number of topics to include: This is an exploratory study, single center, on a rare disease, the incidence of stroke is estimated amnesia of 3 to 8 patients per 100 000 per year according to recent studies.
/ COURSE OF STUDY
2.1 Patients and MRI
Only patients referred for achieving their brain MRI as part of a typical transient global amnesia in the Radiology Department of the Paris Saint Joseph Hospital Group will be included in succession.
For each subject, the following clinical data will be collected:
In the acute phase, there is no change in the usual care of the patient. The patient has a consultation with a neurologist at D0 / D1 which ensures the typical character of the clinical presentation.
An MRI is performed on day 2 of the onset of symptoms to confirm the diagnosis.
The usual course of MRI is not modified in any way, it includes the reception of the patient, information on the MRI scan and search against-indications. The images are acquired using a 3T MRI (GE Discovery MR 750) with 32 elements antenna head. The conventional imaging protocol includes the DTI sequences, FLAIR and 3DT1 without gadolinium (or 15 minutes of acquisition). As part of the study, it is not directed modification of the imaging protocol.
Changes in the management of patients related to the application of this protocol are:
o neurological consultation with neuropsychological evaluation
o brain MRI with the same protocol or an acquisition time of 15 minutes without gadolinium.
Study design in Annex 2.
2.1 Post processing
The post processing of the data will be conducted at the research platform of the Lille University Hospital, which specializes in advanced imaging techniques (Prof. Xavier Leclerc, Mr Renaud Lopes), and include the following steps:
Image analysis is done in two stages.
/ interpretation "clinical" images, immediately with the aim to answer the following questions:
4 / STATISTICAL ANALYSIS
Search correlation between connectivity and anomalies o 1 / lateral abnormal hippocampal signal,
3 / abnormal neuropsychological examination
5 / ETHICS / REGULATORY:
This protocol presents no added risk to the patient. The initial MRI examination D2 is routinely performed as part of routine monitoring of patients with IA.
Changes in the management of patients related to the application of this protocol is to renew 1-year episode of AI:
Data processing will be carried out within the research platform of the Lille University Hospital of anonymized way. Collaboration is already underway with this research center with several joint publications in the field of inflammatory and vascular diseases. The principal investigator (Dr. Hodel) exercises in both structures.
To start searching the CRC GHPSJ, as a promoter must submit a permit application to the competent authority (ANSM for biomedical research out health product).
In accordance with Article L.1123-6 of the Public Health Code, the research protocol must be submitted by the proponent to the Patient Protection Committee of choice (CPP Ile de France II). The opinion of the committee is notified to the competent authority by the developer before the start of the research.
When the protocol has a quality control of the data by a CRA representative promoter and enters the scope of the CNIL simplified procedure, the developer will ask the head of the computer file (investigator-coordinator research) to commit to compliance with the methodology of reference MR001 simplified.
The inclusion of patients will occur after the patient's information and collection of written consent; its information and consent will be traced in his file.
The patient's consent is sought:
22 studies on the registry are indexed under Amnesia; 2 are open to participants now.
This study's enrollment of 1 is below the median of 62 across 19 interventional studies indexed under Amnesia.
Browse Amnesia studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
achieving a neuropsychological examination in the acute phase in addition to the normal protocole
Neurological consultation with neuropsychological evaluation one year after the acute amnesic phase
Brain MRI with the same protocol or an acquisition time of 15 minutes without gadolinium, one year after the acute amesic phase
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
Time frame: 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
Time frame: Day 2, 1 year
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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