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Completed

NCT Number: NCT04240405

Effects of Episodic Specificity Induction in 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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire d'Étude des Mécanismes Cognitifs, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Average number of internal details

    Time frame: Day 0 (at inclusion)

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: INSPE

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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