Effects of Episodic Specificity Induction in Normal and Pathological Ageing. (INSPE)

Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.

Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Bron, France, 69676
    • Laboratoire d'Etude des Mécanismes Cognitifs
  • Villeurbanne, France, 69100
    • Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study looks at a population of adults between the ages of 55 and 85 and 3 types of sample of subjects extracted from this population :

1. 24 elderly people without cognitive impairment
2. 24 amnestic type mild cognitive impairment patients (aMCI)
3. 24 dysexecutive type mild cognitive impairment patients (dMCI)

Description

Inclusion Criteria:

The participant:

• has provided informed consent obtained in accordance with Good Clinical Practices.
• is affiliated to a social security system.
• speaks fluent French.
• is between 55 and 85 years of age.

For the participants of the control group:

• has a Montreal Cognitive Assessment (MoCA) score equal to or greater than 26;
• has neuropsychological assessment performance (RL/RI 16, D080, TMT, VOSP, Rey's figure) in the norm according to his socio-professional category and age, i.e. less than two deviating scores of -1 standard deviation or less than the 10th percentile per function.

For patients in the TCLa group:

• has at least two scores below the 10th percentile or below -1 standard deviation from the norm on neuropsychological assessment tests that assess memory, based on its socio-professional category and age;
• has less than two scores below the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess other functions. This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).

For patients in the TCLd group:

• has focal executive dysfunction expressed by at least two scores less than the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess executive functions (TMT, Stroop, verbal fluences, free recall in memory), according to his socio-professional category and age;
• has less than two scores below the 10th percentile or less than -1 standard deviation from the norm on neuropsychological assessment tests that assess other functions (except for free memory reminders and language fluences). This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).

Exclusion Criteria:

The participant:

• meets the criteria for a major neurocognitive disorder of the DSM-5.
• has a neurological disorder of infectious origin.
• has a psychiatric illness.
• has a severe uncompensated sensory deficit.
• is a substance abuser.
• has had chronic depression or anxiety that has not stabilized for 3 months.
• refuses to participate.
• is participating in another intervention research project.
• is placed under the protection of justice.
• refuses to sign the consent form.
• is unable to express its consent.
• consumed toxic substances or alcohol at the time of the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Elderly people without cognitive impairment
Amnestic type mild cognitive impairment patients (aMCI)
Dysexecutive type mild cognitive impairment patients (dMCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of internal details	The participant sees 5 images evoking various events (e.g., a birthday, a restaurant) and describes for each one a related memory for 3 minutes. Each verbal production is recorded with a dictaphone, transcribed and then segmented into internal (episodic) or external (non-episodic) details according the coding procedure of Levine et al. (2002). The average number of internal details by autobiographical recall task is then calculated from these data.	Day 0 (at inclusion)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: 69HCL19-0373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No