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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04548037
Other study ID # NIMAO/2019-01/CH-01
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 30, 2022
Est. completion date June 12, 2023

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 12, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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). Exclusion criteria for the target population: • Patients will be excluded after the 1st neuropsychological assessment if episodic memory tests show complete recovery from anterograde amnesia.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PET-CT examination
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.

Locations

Country Name City State
France CHU de Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Day 0
Primary Ability to judge the degree of activation and emotional value associated with images Self Assessment Manikin (SAM) Day 0
Secondary 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). Day 3
Secondary 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). Month 3
Secondary Classification of event triggering transient global amnesia Psychological/physiological Day 0
Secondary Anxiety Hamilton Scale: where score = 7 is absence of depression; 8-15 is minor depression and 16 or more is severe depression Day 0
Secondary Depression Beck Depression Scale Day 0
Secondary Mood Befindlichkeits Skala Mood Scale Day 0
Secondary 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 Day 0
Secondary 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. Day 0
Secondary 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 Day 0