AmnesiaICTUSNCT02010853
Transient Global Amnesia (TGA). Exploratory Study of the Default Mode Network During the Acute Phase
A study testing IRMf in people with Amnesia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amnesia
- What is being tested?
- IRMf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase
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.
Read more
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.
Read the 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.
- Conditions
- Amnesia
- Being tested
- IRMf
- Keywords
- Transient Global amnesia, fMRI, resting state
- Medical subject headings
- Amnesia, Amnesia, Transient Global
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRMfOther
evaluation in resting state fMRI during three successive visits:
- During the acute phase within 24 hours
- In 72 hours
- In 3 months
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | 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 Receives: Other: IRMf |
| control | Other | 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 Receives: Other: IRMf |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary judgment criteria will be the difference in activation probabilistic resting state maps between patient and control groups during the acute phase.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmnesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PrJérémie Pariente, PHD, Principal investigator, Department of Neurology, Purpan Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010853
- Sponsor's protocol ID
- 13 201 02
- Other IDs
- 2013-A01271-44
- Acronym
- ICTUS
- Status last verified
- Mar 2017
- First submitted
- 4 Dec 2013
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase
- ClinicalTrials.gov ID
- NCT02010853
- Acronym / sponsor ID
- ICTUS / 13 201 02
- Conditions
- Amnesia
- Keywords
- Transient Global amnesia, fMRI, resting state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: IRMfeach 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 |
| control | Other | Other: IRMfeach 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient group
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRMfevaluation in resting state fMRI during three successive visits: * During the acute phase within 24 hours * In 72 hours * In 3 months | Other | control, patient |
Primary outcome
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
1 secondary outcome
memory performance tests and functional activity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PrJérémie Pariente, PHD principal investigator
Department of Neurology, Purpan Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRMf in people with Amnesia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.