Mild Cognitive ImpairmentEVASIONNCT05791994
EVASION: Effect of VisuAl Stimulation on attentION
A study testing Visual cognitive stimulation exercises and Broadcast of a television program in people with Mild Cognitive Impairment, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Visual cognitive stimulation exercises and Broadcast of a television program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers
Marine ASFAR, MD, +33 2 41 35 47 25, marine.asfar@chu-angers.fr
About this study
Official title: Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Visual cognitive stimulation exercises, Broadcast of a television program
- Keywords
- Geriatrics, Cognitive impairment, Visual stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual cognitive stimulation exercisesProcedure or surgery
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.
Broadcast of a television programProcedure or surgery
Patients included in Comparator group will watch a 30-minute television program (Allô Docteurs) on a touch screen every other day for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Procedure: Visual cognitive stimulation exercises |
| Comparator group | Active comparator | Not described Receives: Procedure: Broadcast of a television program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in information processing speed
Changes in information processing speed is assessed by processing speed index
Measured: Baseline and after 30 days of intervention
Secondary outcomes (8)
Changes in information processing speed of each subtest
This outcome is assessed by Symbol Search end Coding scores
Measured: Baseline and after 30 days of intervention
Changes in cognitive performance
This outcome is assessed by ADAS-cog score
Measured: Baseline and after 30 days of intervention
Changes in executive functions (cognitive flexibility)
Cognitive flexibility is measured by time needed to perform the Trail-Making Test (TMT) part B minus A
Measured: Baseline and after 30 days of intervention
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
Measured: Baseline and after 30 days of intervention
Changes in executive functions (working memory updating)
Working memory updating is assessed by digit span test
Measured: Baseline and after 30 days of intervention
Changes in walking performance
Changes in walking performance is assessed by changes in coefficient of variation of stride time
Measured: Baseline and after 30 days of intervention
Changes in quality of life
Quality of life is assessed by 36-Item Short Form Health Survey (SF-36)
Measured: 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
This outcome is assessed by the final level achieved for each cognitive stimulation exercise
Measured: After 30 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791994
- Sponsor's protocol ID
- 2023-A00235-40
- Acronym
- EVASION
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)
- ClinicalTrials.gov ID
- NCT05791994
- Acronym / sponsor ID
- EVASION / 2023-A00235-40
- Conditions
- Mild Cognitive Impairment
- Keywords
- Geriatrics, Cognitive impairment, Visual stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Visual cognitive stimulation exercises |
| Comparator group | Active comparator | Procedure: Broadcast of a television program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual cognitive stimulation exercisesPatients 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. | Procedure or surgery | Intervention group |
| Broadcast of a television programPatients included in Comparator group will watch a 30-minute television program (Allô Docteurs) on a touch screen every other day for 30 days. | Procedure or surgery | Comparator group |
Primary outcome
Changes in information processing speed
Time frame: Baseline and after 30 days of intervention
Changes in information processing speed is assessed by processing speed index
8 secondary outcomes
Changes in information processing speed of each subtest
Time frame: Baseline and after 30 days of intervention
Changes in cognitive performance
Time frame: Baseline and after 30 days of intervention
Changes in executive functions (cognitive flexibility)
Time frame: Baseline and after 30 days of intervention
Changes in executive functions (cognitive inhibition)
Time frame: Baseline and after 30 days of intervention
Changes in executive functions (working memory updating)
Time frame: Baseline and after 30 days of intervention
Changes in walking performance
Time frame: Baseline and after 30 days of intervention
Changes in quality of life
Time frame: 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
Time frame: After 30 days of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual cognitive stimulation exercises and Broadcast of a television program in people with Mild Cognitive Impairment, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine ASFAR, MD (+33 2 41 35 47 25, marine.asfar@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in information processing speed (time frame: Baseline and after 30 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.