Clinical trial NCT05791994: EVASION: Effect of VisuAl Stimulation on attentION
Official title: Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysexecutive Mild Cognitive Impairment
Keywords: Geriatrics
Cognitive impairment
Visual stimulation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective is to compare changes in information processing speed after 30 days of intervention in participants with a dysexecutive mild cognitive impairment (MCI) and receiving either cognitive stimulation by adapted visual exercises (Emeraude® software) or the broadcasting of a television program without cognitive stimulation.

Secondary objectives are:

* To compare, after 30 days of intervention, in participants with a dysexecutive MCI and receiving either cognitive stimulation by adapted visual exercises (Emeraude® software), or the broadcasting of a television program without cognitive stimulation :
* changes in information processing speed of each subtest,
* changes in cognitive performance,
* changes in executive functions,
* changes in walking performance.
* To compare the quality of life, after 30 days of intervention, of participants with a dysexecutive MCI and receiving either cognitive stimulation by adapted visual exercises (Emeraude® software) or the broadcasting of a television program without cognitive stimulation.
* In the "Intervention" group, to study correlations between changes in information processing speed index and the final level reached for each cognitive stimulation exercise.

Detailed description: Attentional abilities are among the cognitive functions that are most frequently and earliest altered during aging, particularly in the case of neurodegenerative diseases such as Alzheimer's disease. This decline can be the cause of a cognitive complaint in the patient or his relatives from the prodromal stage of the disease. This mild cognitive impairment is not sufficiently advanced to have an impact on independence and autonomy, even though recent studies have reported an early modification of walking in this population, in particular in the case of a dysexecutive MCI. The current challenge is to develop strategies to prevent cognitive decline in these patients with MCI and to avoid conversion to major neurocognitive disorders. However, while "memory workshops" are offered to patients with amnestic MCI, no strategy is clearly identified for dysexecutive MCI.

Interestingly, the integration of sensory information is modified in patients with neurodegenerative diseases, and in particular visuomotor difficulties in the early stages. Measurements of evoked potentials during visual stimulation have shown that sensory responses are preserved but cognitive responses are reduced in patients with MCI. Based on this observation, an American team recently tested the effectiveness of computer-assisted visual cognitive exercises performed regularly for 8 weeks in patients without dementia, and reported an improvement in information processing speed and walking performance. These results lead us to hypothesize that regular cognitive stimulation exercises using adapted visual exercises could improve the attentional capacities and in particular the information processing speed (=mental speed) of elderly people with a dysexecutive MCI.

A complex brain stimulation software Emeraude® has recently been developed by the Centre Régional Basse Vision in Angers from a software used for more than 30 years in people with visual impairment.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Diagnosis of mild cognitive impairment of a dysexecutive or multidomain dysexecutive nature, according to Winblad consensus criteria
* Presence of an informal caregiver
* Subject gave and signed informed consent to participate in the study
* Affiliation to a social security scheme

Exclusion Criteria:

* Presence of severe depressive symptoms (4-item Geriatric Depression Scale score \> 2)
* Ophthalmological or central pathology that may affect the performance of stimulation exercises
* Regular use of psychotropic drugs that may have an impact on the performance of stimulation exercises, in the opinion of the investigator (benzodiazepines, antidepressants, neuroleptics, hypnotics)
* Use of anticonvulsant drugs
* Existence of a confusional syndrome
* Participation in another simultaneous clinical trial
* Person deprived of liberty by judicial or administrative decision
* Person under forced psychiatric care
* Person subject to a legal protection measure
* Person unable to give consent

Primary outcomes:
measure: Changes in information processing speed
timeFrame: Baseline and after 30 days of intervention
Secondary outcomes:
measure: Changes in information processing speed of each subtest
timeFrame: Baseline and after 30 days of intervention
measure: Changes in cognitive performance
timeFrame: Baseline and after 30 days of intervention
measure: Changes in executive functions (cognitive flexibility)
timeFrame: Baseline and after 30 days of intervention
measure: Changes in executive functions (cognitive inhibition)
timeFrame: Baseline and after 30 days of intervention
measure: Changes in executive functions (working memory updating)
timeFrame: Baseline and after 30 days of intervention
measure: Changes in walking performance
timeFrame: Baseline and after 30 days of intervention
measure: Changes in quality of life
timeFrame: Baseline and after 30 days of intervention
measure: Correlations between changes in information processing speed index and the final level reached for each cognitive stimulation exercise
timeFrame: After 30 days of intervention
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
References: