Assessment of Emotional Memory During Transient Global Amnesia (EMOTICTUS)

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 Overview

• Status: Terminated
• Conditions: Amnesia, Transient Global
• Intervention / Treatment: Other: PET-CT examination

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers
Patients with transient global amnesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Ability to judge the degree of activation and emotional value associated with images	Self Assessment Manikin (SAM)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Classification of event triggering transient global amnesia	Psychological/physiological	Day 0
Anxiety	Hamilton Scale: where score = 7 is absence of depression; 8-15 is minor depression and 16 or more is severe depression	Day 0
Depression	Beck Depression Scale	Day 0
Mood	Befindlichkeits Skala Mood Scale	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	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.	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	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Eric Thouvenot, CHU Nimes

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Memory Disorders; Amnesia; Amnesia, Transient Global
• Other Study ID Numbers: NIMAO/2019-01/CH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No