ClinicalTrials.Veeva

Menu

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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Neurocognitive Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT04240405
69HCL19-0373

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

42 participants in 3 patient groups

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

Trial contacts and locations

2

Loading...

Central trial contact

Floriane DELPHIN-COMBE; Marie-Helene COSTE, PR

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems