A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
Effects of a Computer-based Cognitive Stimulation on the Verbal Learning and the Progression of White Matter Hyperintensities in Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial.
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
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
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJune 22, 2017
June 1, 2017
11 months
June 14, 2017
June 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change on Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory
Baseline assessment in 3-weeks period before intervention, change from baseline at 6-months immediately after the end intervention, and after 3-months follow-up
Secondary Outcomes (1)
Change on Fazekas scale
Baseline assessment of WMH severity and evolution at 12 months immediately after intervention
Study Arms (2)
computerized Cognitive training
EXPERIMENTALExperimental group will receive 1 year of a computer-based cognitive stimulation program.
MCI control group
NO INTERVENTIONThe control group will receive a usual standard care without engagement in intervention
Interventions
Experimental group will receive 1 year of a computer-based cognitive stimulation program, first 6 months, 60-minutes twice a week and next 6 months once a week training in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Mild Cognitive Impairment
- With and without with matter hyperintensities
- MRI data available or accept to perform one
- No engagement in other cognitive intervention program
You may not qualify if:
- Psychiatric and neurological disorders
- History of alcohol or other substance consumption
- Sensory and or motor deficit that could interfere with the use of computer tool
- Refusal MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leila DJABELKHIRlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Sophie AR RIGAUD, Professor
Broca University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 22, 2017
Study Start
January 1, 2018
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share