Assessment of Emotional Memory During Transient Global Amnesia

NCT04548037 | Terminated

• 1 other identifier: NIMAO/2019-01/CH-01
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amnesia, Transient Global

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline

  Day 3

• Change in storage and retrieval capacities of information with a strong emotional valence in patients from baseline

  Month 3

• Classification of event triggering transient global amnesia

  Day 0

• Anxiety

  Day 0

• Depression

  Day 0

Study Arms (2)

Patients with transient global amnesia

Other: PET-CT examination

Healthy volunteers

Interventions

PET-CT examination OTHER

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.

Patients with transient global amnesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Amnesia, Transient Global

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amnesia; Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eric THOUVENOT

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: May 30, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

FR (1)