EVASION: Effect of VisuAl Stimulation on attentION
EVASION
Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
October 1, 2025
September 1, 2025
1.3 years
March 17, 2023
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in information processing speed
Changes in information processing speed is assessed by processing speed index
Baseline and after 30 days of intervention
Secondary Outcomes (8)
Changes in information processing speed of each subtest
Baseline and after 30 days of intervention
Changes in cognitive performance
Baseline and after 30 days of intervention
Changes in executive functions (cognitive flexibility)
Baseline and after 30 days of intervention
Changes in executive functions (cognitive inhibition)
Baseline and after 30 days of intervention
Changes in executive functions (working memory updating)
Baseline and after 30 days of intervention
- +3 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALComparator group
ACTIVE COMPARATORInterventions
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.
Patients included in Comparator group will watch a 30-minute television program (Allô Docteurs) on a touch screen every other day for 30 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angers University Hospital
Angers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2023
First Posted
March 30, 2023
Study Start
October 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.