Effects of Episodic Specificity Induction in Normal and Pathological Ageing.

Neurocognitive Disorders Clinical Trial

— INSPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240405
• Other study ID #: 69HCL19-0373
• Status: Recruiting
• Start date: December 11, 2019
• Est. completion date: February 11, 2024

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Marie-Helene COSTE, PR
• Phone: 4 72 43 20 76
• Email: marie-helene.coste[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 11, 2024
• Est. primary completion date: February 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Disorders

Locations

Country	Name	City	State
France	Laboratoire d'Étude des Mécanismes Cognitifs	Bron
France	Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)