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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

Tracking Information
First Submitted Date January 22, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Estimated Study Start Date January 31, 2020
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Episodic Specificity Induction in Normal and Pathological Ageing.
Official Title Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Neurocognitive Disorders
Intervention Not Provided
Study Groups/Cohorts
  • Elderly people without cognitive impairment
  • Amnestic type mild cognitive impairment patients (aMCI)
  • Dysexecutive type mild cognitive impairment patients (dMCI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 22, 2020)
72
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240405
Other Study ID Numbers 69HCL19-0373
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2020