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

Primary Purpose

Amnesia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IRMf
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amnesia focused on measuring Transient Global amnesia, fMRI, resting state

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patient

control

Arm Description

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

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

Outcomes

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.

Secondary Outcome Measures

memory performance tests and functional activity
The correlation coefficient between memory performance tests and functional activity observed in resting state fMRI in the group of patients.

Full Information

First Posted
December 4, 2013
Last Updated
March 12, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02010853
Brief Title
Transient Global Amnesia (TGA). Exploratory Study of the Default Mode Network During the Acute Phase
Acronym
ICTUS
Official Title
Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 100,000 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: It's 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, Alzheimer's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnesia
Keywords
Transient Global amnesia, fMRI, resting state

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
IRMf
Intervention Description
evaluation in resting state fMRI during three successive visits: During the acute phase within 24 hours In 72 hours In 3 months
Primary Outcome Measure Information:
Title
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 months
Secondary Outcome Measure Information:
Title
memory performance tests and functional activity
Description
The correlation coefficient between memory performance tests and functional activity observed in resting state fMRI in the group of patients.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PrJérémie Pariente, PHD
Organizational Affiliation
Department of Neurology, Purpan Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Purpan
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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