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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240405
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease
Neurocognitive Disorders

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240405


Contacts
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Contact: Pierre KROLAK-SALMON, PR 4 72 43 20 50 ext +33 pierre.krolak-salmon@chu-lyon.fr
Contact: Floriane DELPHIN-COMBE 4 72 43 31 35 ext +33 floriane.delphin-combe@chu-lyon.fr

Locations
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France
Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes
Villeurbanne, France, 69100
Contact: Pierre KROLAK-SALMON, PR    4 72 43 20 50 ext +33    pierre.krolak-salmon@chu-lyon.fr   
Contact: Floriane DELPHIN-COMBE    4 72 43 31 35 ext +33    floriane.delphin-combe@chu-lyon.fr   
Principal Investigator: Pierre KROLAK-SALMON, PR         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04240405    
Other Study ID Numbers: 69HCL19-0373
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurocognitive Disorders
Mental Disorders