Transient Global Amnesia (TGA)2NIANCT02562560
Neuropsycholgy and Neuroimaging in Transient Global Amnesia
A study testing Neuropsychological tests and Cerebral imaging (MRI, PET-FDG) in people with Transient Global Amnesia (TGA), run by University Hospital, Caen.
Trial summary
The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Global Amnesia (TGA)
- What is being tested?
- Neuropsychological tests and Cerebral imaging (MRI, PET-FDG)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the participants
- Minimum of 7 years of education
- French native speaker
- Healthy subjects : Non pathological Dementia rating scale score
- Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion
Who cannot join
- Chronic neurological disease
- Encephalitis
- Endocrinal disease
- Hepatic disease
- Case history of head injury with loss of consciousness of more than one hour
- Case history of stroke
Show all 9Show fewer
- Case history of cancer during the five last years except squamous cell carcinomas
- Alcoholism or drug addiction
- Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders
About this study
The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.
- Conditions
- Transient Global Amnesia (TGA)
- Being tested
- Neuropsychological tests, Cerebral imaging (MRI, PET-FDG)
- Medical subject headings
- Amnesia, Transient Global
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsBehavioural
Cerebral imaging (MRI, PET-FDG)Device
| Study group | Role | What they receive |
|---|---|---|
| TGA | Experimental | Not described Receives: Behavioral: Neuropsychological tests; Device: Cerebral imaging (MRI, PET-FDG) |
| Controls | Experimental | Not described Receives: Behavioral: Neuropsychological tests; Device: Cerebral imaging (MRI, PET-FDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory scores
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2008
- Primary completionJul 2015
- Study completionDec 2015
Why it stopped: no more patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Global Amnesia (TGA)Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Diagnosis
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fausto Viader, PUPH, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562560
- Sponsor's protocol ID
- 2007-A00910-53
- Acronym
- 2NIA
- Status last verified
- Nov 2015
- First submitted
- 28 Sep 2015
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsycholgy and Neuroimaging in Transient Global Amnesia
- ClinicalTrials.gov ID
- NCT02562560
- Acronym / sponsor ID
- 2NIA / 2007-A00910-53
- Conditions
- Transient Global Amnesia (TGA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more patient
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2015 (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 purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.
Study design
- Primary purpose
- Diagnosis
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGA | Experimental | Behavioral: Neuropsychological tests, Device: Cerebral imaging (MRI, PET-FDG) |
| Controls | Experimental | Behavioral: Neuropsychological tests, Device: Cerebral imaging (MRI, PET-FDG) |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All the participants
- Healthy subjects : Non pathological Dementia rating scale score
- Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion
Key exclusion criteria (9 listed)
- Chronic neurological disease
- Encephalitis
- Endocrinal disease
- Hepatic disease
- Case history of head injury with loss of consciousness of more than one hour
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 |
|---|---|---|
| Neuropsychological tests | Behavioural | Controls, TGA |
| Cerebral imaging (MRI, PET-FDG) | Device | Controls, TGA |
Primary outcome
Episodic memory scores
Time frame: 3 years
Results and safety
The study was stopped early (reason given: no more patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Related trials for Transient Global Amnesia (TGA)
Not yet recruitingObservational study
Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases
Stroke, Epilepsy
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.
Fausto Viader, PUPH principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests and Cerebral imaging (MRI, PET-FDG) in people with Transient Global Amnesia (TGA), run by University Hospital, Caen.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: no more patient). Results are not available in the source record.
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?
Episodic memory scores (time frame: 3 years). 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 1 Sep 2020.