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.
1 other identifier
observational
42
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2024
CompletedOctober 10, 2024
October 1, 2024
4.4 years
January 22, 2020
October 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (3)
Elderly people without cognitive impairment
Amnestic type mild cognitive impairment patients (aMCI)
Dysexecutive type mild cognitive impairment patients (dMCI)
Eligibility Criteria
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)
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Laboratoire d'Étude des Mécanismes Cognitifs
Bron, 69676, France
Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 27, 2020
Study Start
December 11, 2019
Primary Completion
April 19, 2024
Study Completion
April 19, 2024
Last Updated
October 10, 2024
Record last verified: 2024-10