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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06105047
Other study ID # 23CH154
Secondary ID ANSM
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2024
Est. completion date May 2025

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Céline BORG, MD
Phone (0)477127805
Email celine.borg@univ-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.


Description:

In a within subjects design, all patients take part in four conditions. In each condition, sentences describing actions will be displayed. In a control condition, they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; and in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task. The main criterion used in our statistical analyses will be the discrimination threshold.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria: - Diagnosis of Alzheimer's disease by one of the consulting physicians, neurologist and/or geriatrician of whom the patient has been informed. - Early stage (MMSE = 22) - Neuropsychological assessment within 6 months of inclusion. - Affiliation with a social security scheme - Age equal to or greater than 60 - French mother tongue - Agreement to participate / signature of consent form Exclusion Criteria: - Uncorrected perceptual disorders - Other neurological or psychiatric history - Inability to communicate - Delusional or psychotic state - Person unable to give informed consent - Refusal to participate - Participation in a study on a drug/medical device/care technique likely to affect cognitive functions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive tests
. Patients will perform experimental task in four conditions : control, mime, emotion, dual In a control condition : they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task quiz : Geneva Music Induced Checklist, GMIAC, Coutinho & Scherer, 2017

Locations

Country Name City State
France CHU Grenoble Grenoble
France CHU de Saint-Etienne Saint-Étienne
France HCL Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary "Discrimination score" Comparison of the recognition score obtained in each of the experimental conditions to the recognition score obtained in the control condition The score = the Number of correct answer (0 to 15, the higher score means better outcome) Weeks: 2
Secondary "Geneva Music-Induced Affect Checklist" scale Analysis Geneva Music-Induced Affect Checklist scale results. It is composed of 4 sub-score dimensions such as valence, activation, tension (stress level) and pleasure (14 items scale 1: "not at all" to 5 "hugely, it's a qualitative scale) Weeks: 2
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