Amnesia, Transient GlobalEMOTICTUSNCT04548037
Assessment of Emotional Memory During Transient Global Amnesia
An observational study of Amnesia, Transient Global, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amnesia, Transient Global
- What is being tested?
- PET-CT examination
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2022to 12 Jun 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with a transient global amnesia according to the criteria of Hodges and Warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person and admitted to the SAU of the CHU de Nîmes, plus a group of healthy volunteers.
Who may be able to join
- Subject with no history of transient global amnesia or neurological or psychiatric pathology.
- Patients with a transient global amnesia according to the criteria of Hodges and Warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in another study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
- Presence of a focal neurological pathology that may explain the symptoms, history of epilepsy or psychiatric disorders.
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- Hypersensitivity to iodinated contrast media.
- Known allergy to 18-FDG.
- Non-inclusion criteria concerning control subjects:
- Presence of disorders on neurological assessment
- Presence of cognitive disorders on the neuropsychological assessment (z-score <-1.65 on the RBANS or on the Stroop test).
- Patients will be excluded after the 1st neuropsychological assessment if episodic memory tests show complete recovery from anterograde amnesia.
Trial locations and contacts
1 site in 1 country.
About this study
There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. It would be interesting to see if the patients suffering from TGA triggered by a psychological shock process emotional information differently from those whose TGA was triggered by an "organic" shock (physical effort, trauma, etc.). Finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the CA1 region, in episodic memory.
- Conditions
- Amnesia, Transient Global
- Being tested
- PET-CT examination
- 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.
PET-CT examinationOther
The subject is placed in supine position, the head immobilized in a headrest. The imaging sequence begins with a scout view (viewing angle 90 °, 120 kV, 20 mA), then an X-ray scan is performed for the attenuation correction (120 kV, 5 mAs per slice, pitch 0.531, collimation 40 mm , FOV 70) and diagnostic CT scan (120 kV, 100-250 mA: auto mA, pitch 0.531, 40 MM, DFOV 25, ASIR 60%, thickness 1.25 mm). Finally, the positron emission tomography is acquired: static in 3D mode for 15 minutes, 30 minutes after the injection of 18 FDG, the axial field of view is 25, the matrix in 256 x 256, OSEM reconstruction 6 iterations 24 subsets, attenuation correction, diffused, and PSF. Gaussian filter, cutoff frequency of 4. Obtaining forty-seven contiguous sections of 3.26 mm thick.
| Study group | Role | What they receive |
|---|---|---|
| Patients with transient global amnesia | Not described Receives: Other: PET-CT examination | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Storage and retrieval capacities of information with a strong emotional valence in patients compared to healthy controls
International Affective Picture System (IAPS): number of correctly memorized images of each type of emotional content (15 positive, 15 negative and 15 neutral).
Measured: Day 0
Ability to judge the degree of activation and emotional value associated with images
Self Assessment Manikin (SAM)
Measured: Day 0
Secondary outcomes (9)
Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline
International Affective Picture System (IAPS): number of correctly memorized images of each type of emotional content (15 positive, 15 negative and 15 neutral).
Measured: Day 3
Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline
International Affective Picture System (IAPS): number of correctly memorized images of each type of emotional content (15 positive, 15 negative and 15 neutral).
Measured: Month 3
Classification of event triggering transient global amnesia
Psychological/physiological
Measured: Day 0
Anxiety
Hamilton Scale: where score = 7 is absence of depression; 8-15 is minor depression and 16 or more is severe depression
Measured: Day 0
Depression
Beck Depression Scale
Measured: Day 0
Mood
Befindlichkeits Skala Mood Scale
Measured: Day 0
C-score of the Groupe de REflexion pour l'Evaluation des Fonctions Exécutives (GREFEX) version of Stroop Test between patients and healthy control
Stroop Test
Measured: Day 0
Repeatable Battery for the Assessment of Neuropsychological Status between patients and healthy control
Repeatable Battery for the Assessment of Neuropsychological Status: 10 subtests combined into 5 index scores and 1 total score.
Measured: Day 0
Identification of hypometablic zones by PET compared to age- and sex-matched controls
Visual analysis of hippocampus and other topographies (Z-score); Statistical Parametric Mapping 12
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start30 May 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Why it stopped: Departure of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amnesia, Transient GlobalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric THOUVENOT, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548037
- Sponsor's protocol ID
- NIMAO/2019-01/CH-01
- Acronym
- EMOTICTUS
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Emotional Memory During Transient Global Amnesia
- ClinicalTrials.gov ID
- NCT04548037
- Acronym / sponsor ID
- EMOTICTUS / NIMAO/2019-01/CH-01
- Conditions
- Amnesia, Transient Global
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Departure of the principal investigator
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- 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.
There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. It would be interesting to see if the patients suffering from TGA triggered by a psychological shock process emotional information differently from those whose TGA was triggered by an "organic" shock (physical effort, trauma, etc.). Finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the CA1 region, in episodic memory.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with transient global amnesia | – | Other: PET-CT examination |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a transient global amnesia according to the criteria of Hodges and Warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person and admitted to the SAU of the CHU de Nîmes, plus a group of healthy volunteers.
Key inclusion criteria (4 listed)
- Subject with no history of transient global amnesia or neurological or psychiatric pathology.
- Patients with a transient global amnesia according to the criteria of Hodges and Warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (12 listed)
- The subject is participating in another study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
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 |
|---|---|---|
| PET-CT examinationThe subject is placed in supine position, the head immobilized in a headrest. The imaging sequence begins with a scout view (viewing angle 90 °, 120 kV, 20 mA), then an X-ray scan is performed for the attenuation correction (120 kV, 5 mAs per slice, pitch 0.531, collimation 40 mm , FOV 70) and diagnostic CT scan (120 kV, 100-250 mA: auto mA, pitch 0.531, 40 MM, DFOV 25, ASIR 60%, thickness 1.25 mm). Finally, the positron emission tomography is acquired: static in 3D mode for 15 minutes, 30 minutes after the injection of 18 FDG, the axial field of view is 25, the matrix in 256 x 256, OSEM reconstruction 6 iterations 24 subsets, attenuation correction, diffused, and PSF. Gaussian filter, cutoff frequency of 4. Obtaining forty-seven contiguous sections of 3.26 mm thick. | Other | Patients with transient global amnesia |
Primary outcome
Storage and retrieval capacities of information with a strong emotional valence in patients compared to healthy controls
Time frame: Day 0
International Affective Picture System (IAPS): number of correctly memorized images of each type of emotional content (15 positive, 15 negative and 15 neutral).
Ability to judge the degree of activation and emotional value associated with images
Time frame: Day 0
Self Assessment Manikin (SAM)
9 secondary outcomes
Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline
Time frame: Day 3
Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline
Time frame: Month 3
Classification of event triggering transient global amnesia
Time frame: Day 0
Anxiety
Time frame: Day 0
Depression
Time frame: Day 0
Mood
Time frame: Day 0
C-score of the Groupe de REflexion pour l'Evaluation des Fonctions Exécutives (GREFEX) version of Stroop Test between patients and healthy control
Time frame: Day 0
Repeatable Battery for the Assessment of Neuropsychological Status between patients and healthy control
Time frame: Day 0
Identification of hypometablic zones by PET compared to age- and sex-matched controls
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Departure of the principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Eric THOUVENOT principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amnesia, Transient Global, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 12 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 8 Feb 2024. 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 was stopped early (reason given: Departure of the principal investigator). 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?
Storage and retrieval capacities of information with a strong emotional valence in patients compared to healthy controls (time frame: Day 0). The study lists 2 primary outcomes in all. 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 8 Feb 2024.