Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010853
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2013-12-04
Brief Title:
Transient Global Amnesia TGA Exploratory Study of the Default Mode Network During the Acute Phase
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Transient Global Amnesia TGA Exploratory Study of the Default Mode Network in Resting State Functional MRI fMRI During the Acute Phase
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICTUS
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
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
Detailed Description:
Background
The transient global amnesia is a transient massive and pure memory disorder Its pathophysiology is poorly known but the disease process involves the Papez circuitry and more specifically the medial part of the temporal lobes hippocampi It involves 3-8 per 100000 people per year The age of patients affected is between 50 and 70 years Structural MRI can confirm the diagnosis by revealing a focal and selective lesion located on the CA1 region of the hippocampus better observed between 48h and 72h after onset of the episode
Main purpose
The main aim of this study is to identify neuronal functional impairment in a group of patients vs a group of healthy subjects during the acute phase of transient global amnesia TGA using resting state fMRI imaging
Secondary purpose
Show correlations between functional activity observed in resting state fMRI at the acute phase and cognitive performance in the patient group
Describe the evolution of functional impairment in resting state fMRI between the acute phase visit 1 and post-acute phases visit 2 and 3 in the patient group compared to the control group subjects
Study design
Monocentric pilot prospective controlled study including consecutive patients admitted to the emergency department of the CHU of Toulouse for transient global amnesia investigators will compare two independent groups patients and controls We expect three months between the signing of consent and the end of the study The total duration of the study will not exceed 27 months
Arm number or label and arm type This study is exploratory investigators will compare two independent groups patients and controls
Interventions
After signing the informed consent each patient TGA will receive a neuropsychological assessment a topographic MRI and an evaluation in resting state fMRI during three successive visits
During the acute phase within 24 hours
In 72 hours
In 3 months
Number of subjects
Its difficult to estimate the number of subjects required to show a difference in resting state between the two groups during the acute phase of TGA No study of that type in the literature is available to estimate the sample size to be recruited In this pilot study we will recruit 22 subjects in each group
Expected benefits
The transient global amnesia is a model for exploring memory because this disorder is massive pure and temporary Better understand the Neural Network substrates underlying this alteration could help to better understand memory disorders in other diseases Korsakoff syndrome thalamic stroke dissociative amnesia Alzheimers disease Such discovery could lead to clinical trials of functional brain stimulation as recently developed in other neurological disorders in which functional impairment has been shown TMS TDCS
Statistical analysis
The SPM8 software will be used to generate activation map using fMRI images The obtained maps will be compared between groups using t test imbedded in the same software Correlation maps between cognitive performance and activation will be also calculated Intra group comparison across time will then be assessed
The transient global amnesia is a transient massive and pure memory disorder Its pathophysiology is poorly known but the disease process involves the Papez circuitry and more specifically the medial part of the temporal lobes hippocampi It involves 3-8 per 100000 people per year The age of patients affected is between 50 and 70 years Structural MRI can confirm the diagnosis by revealing a focal and selective lesion located on the CA1 region of the hippocampus better observed between 48h and 72h after onset of the episode
Main purpose
The main aim of this study is to identify neuronal functional impairment in a group of patients vs a group of healthy subjects during the acute phase of transient global amnesia TGA using resting state fMRI imaging
Secondary purpose
Show correlations between functional activity observed in resting state fMRI at the acute phase and cognitive performance in the patient group
Describe the evolution of functional impairment in resting state fMRI between the acute phase visit 1 and post-acute phases visit 2 and 3 in the patient group compared to the control group subjects
Study design
Monocentric pilot prospective controlled study including consecutive patients admitted to the emergency department of the CHU of Toulouse for transient global amnesia investigators will compare two independent groups patients and controls We expect three months between the signing of consent and the end of the study The total duration of the study will not exceed 27 months
Arm number or label and arm type This study is exploratory investigators will compare two independent groups patients and controls
Interventions
After signing the informed consent each patient TGA will receive a neuropsychological assessment a topographic MRI and an evaluation in resting state fMRI during three successive visits
During the acute phase within 24 hours
In 72 hours
In 3 months
Number of subjects
Its difficult to estimate the number of subjects required to show a difference in resting state between the two groups during the acute phase of TGA No study of that type in the literature is available to estimate the sample size to be recruited In this pilot study we will recruit 22 subjects in each group
Expected benefits
The transient global amnesia is a model for exploring memory because this disorder is massive pure and temporary Better understand the Neural Network substrates underlying this alteration could help to better understand memory disorders in other diseases Korsakoff syndrome thalamic stroke dissociative amnesia Alzheimers disease Such discovery could lead to clinical trials of functional brain stimulation as recently developed in other neurological disorders in which functional impairment has been shown TMS TDCS
Statistical analysis
The SPM8 software will be used to generate activation map using fMRI images The obtained maps will be compared between groups using t test imbedded in the same software Correlation maps between cognitive performance and activation will be also calculated Intra group comparison across time will then be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-A01271-44 | OTHER | ANSM -IDRCB | None |