EVASION: Effect of VisuAl Stimulation on attentION

Официальное название

Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Visual cognitive stimulation exercises
  Patients included in Intervention group will receive a 30-minute session of complex visual stimuli on a touch screen (3 10-minute exercises : saccade exercises, then pursuit exercises, then matching exercises) every other day for 30 days, with increasing difficulty of the exercises as the sessions progress.
• Процедура Broadcast of a television program
  Patients included in Comparator group will watch a 30-minute television program (Allô Docteurs) on a touch screen every other day for 30 days.

Первичные конечные точки

• Changes in information processing speed [Срок оценки: Baseline and after 30 days of intervention]

Вторичные конечные точки (8)

• Changes in information processing speed of each subtest [Срок оценки: Baseline and after 30 days of intervention]
• Changes in cognitive performance [Срок оценки: Baseline and after 30 days of intervention]
• Changes in executive functions (cognitive flexibility) [Срок оценки: Baseline and after 30 days of intervention]
• Changes in executive functions (cognitive inhibition) [Срок оценки: Baseline and after 30 days of intervention]
• Changes in executive functions (working memory updating) [Срок оценки: Baseline and after 30 days of intervention]
• Changes in walking performance [Срок оценки: Baseline and after 30 days of intervention]
• Changes in quality of life [Срок оценки: Baseline and after 30 days of intervention]
• Correlations between changes in information processing speed index and the final level reached for each cognitive stimulation exercise [Срок оценки: After 30 days of intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Angers University Hospital — Angers

Идентификаторы

NCT: NCT05791994 · 2023-A00235-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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