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EVASION: Effect of VisuAl Stimulation on attentION

U

University Hospital, Angers

Status

Not yet enrolling

Conditions

Mild Cognitive Impairment

Treatments

Procedure: Broadcast of a television program
Procedure: Visual cognitive stimulation exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT05791994
2023-A00235-40

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Intervention group
Experimental group
Treatment:
Procedure: Visual cognitive stimulation exercises
Comparator group
Active Comparator group
Treatment:
Procedure: Broadcast of a television program

Trial contacts and locations

1

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Central trial contact

Marine ASFAR, MD

Data sourced from clinicaltrials.gov

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