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EVASION: Effect of VisuAl Stimulation on attentION (EVASION)

Primary Purpose

Dysexecutive Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visual cognitive stimulation exercises
Broadcast of a television program
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysexecutive Mild Cognitive Impairment focused on measuring Geriatrics, Cognitive impairment, Visual stimulation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Angers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Comparator group

Arm Description

Outcomes

Primary Outcome Measures

Changes in information processing speed
Changes in information processing speed is assessed by processing speed index

Secondary Outcome Measures

Changes in information processing speed of each subtest
This outcome is assessed by Symbol Search end Coding scores
Changes in cognitive performance
This outcome is assessed by ADAS-cog score
Changes in executive functions (cognitive flexibility)
Cognitive flexibility is measured by time needed to perform the Trail-Making Test (TMT) part B minus A
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
Changes in executive functions (working memory updating)
Working memory updating is assessed by digit span test
Changes in walking performance
Changes in walking performance is assessed by changes in coefficient of variation of stride time
Changes in quality of life
Quality of life is assessed by 36-Item Short Form Health Survey (SF-36)
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

Full Information

First Posted
March 17, 2023
Last Updated
March 17, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT05791994
Brief Title
EVASION: Effect of VisuAl Stimulation on attentION
Acronym
EVASION
Official Title
Effet d'Exercices Visuels de Stimulation Cognitive Sur Les capacités Attentionnelles Chez la Personne âgée (Etude Pilote)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysexecutive Mild Cognitive Impairment
Keywords
Geriatrics, Cognitive impairment, Visual stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Comparator group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Visual cognitive stimulation exercises
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Broadcast of a television program
Intervention Description
Patients included in Comparator group will watch a 30-minute television program (Allô Docteurs) on a touch screen every other day for 30 days.
Primary Outcome Measure Information:
Title
Changes in information processing speed
Description
Changes in information processing speed is assessed by processing speed index
Time Frame
Baseline and after 30 days of intervention
Secondary Outcome Measure Information:
Title
Changes in information processing speed of each subtest
Description
This outcome is assessed by Symbol Search end Coding scores
Time Frame
Baseline and after 30 days of intervention
Title
Changes in cognitive performance
Description
This outcome is assessed by ADAS-cog score
Time Frame
Baseline and after 30 days of intervention
Title
Changes in executive functions (cognitive flexibility)
Description
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
Title
Changes in executive functions (cognitive inhibition)
Description
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
Title
Changes in executive functions (working memory updating)
Description
Working memory updating is assessed by digit span test
Time Frame
Baseline and after 30 days of intervention
Title
Changes in walking performance
Description
Changes in walking performance is assessed by changes in coefficient of variation of stride time
Time Frame
Baseline and after 30 days of intervention
Title
Changes in quality of life
Description
Quality of life is assessed by 36-Item Short Form Health Survey (SF-36)
Time Frame
Baseline and after 30 days of intervention
Title
Correlations between changes in information processing speed index and the final level reached for each cognitive stimulation exercise
Description
This outcome is assessed by the final level achieved for each cognitive stimulation exercise
Time Frame
After 30 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine ASFAR, MD
Phone
+33 2 41 35 47 25
Email
marine.asfar@chu-angers.fr
Facility Information:
Facility Name
Angers University Hospital
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine ASFAR, MD
Phone
+33 2 41 35 47 25
Email
marine.asfar@chu-angers.fr

12. IPD Sharing Statement

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