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RecruitingNCT05791994EVASIONUpdated Apr 6, 2026

EVASION: Effect of VisuAl Stimulation on attentION

An interventional study of Visual cognitive stimulation exercises and Broadcast of a television program in Mild Cognitive Impairment, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.
Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Geriatrics
  • Cognitive impairment
  • Visual stimulation
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Procedure: Visual cognitive stimulation exercises

  • Active comparator
    Comparator group

    Procedure: Broadcast of a television program

Interventions

  • ProcedureVisual 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.

  • ProcedureBroadcast 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.

06

What researchers measure

Primary outcomes

  1. Changes in information processing speed

    Changes in information processing speed is assessed by processing speed index

    Time frame: Baseline and after 30 days of intervention

Secondary outcomes

  1. Changes in information processing speed of each subtest

    This outcome is assessed by Symbol Search end Coding scores

    Time frame: Baseline and after 30 days of intervention

  2. Changes in cognitive performance

    This outcome is assessed by ADAS-cog score

    Time frame: Baseline and after 30 days of intervention

  3. Changes in executive functions (cognitive flexibility)

    Cognitive flexibility is measured by time needed to perform the Trail-Making Test (TMT) part B minus A

    Time frame: Baseline and after 30 days of intervention

  4. Changes in executive functions (cognitive inhibition)

    Cognitive inhibition is measured by time needed to perform the interference task minus the time needed to perform the denomination task

    Time frame: Baseline and after 30 days of intervention

  5. Changes in executive functions (working memory updating)

    Working memory updating is assessed by digit span test

    Time frame: Baseline and after 30 days of intervention

  6. Changes in walking performance

    Changes in walking performance is assessed by changes in coefficient of variation of stride time

    Time frame: Baseline and after 30 days of intervention

  7. Changes in quality of life

    Quality of life is assessed by 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline and after 30 days of intervention

  8. Correlations between changes in information processing speed index and the final level reached for each cognitive stimulation exercise

    This outcome is assessed by the final level achieved for each cognitive stimulation exercise

    Time frame: After 30 days of intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05791994
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Mar 30, 2023
Start date
Jul 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Marine ASFAR, MD
Contact
marine.asfar@chu-angers.fr
+33 2 41 35 47 25

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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