A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Cognitive training
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, white matter hyperintensities, computerized cognitive training, brain plasticity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
computerized Cognitive training
MCI control group
Arm Description
Experimental group will receive 1 year of a computer-based cognitive stimulation program.
The control group will receive a usual standard care without engagement in intervention
Outcomes
Primary Outcome Measures
Change on Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory
Secondary Outcome Measures
Change on Fazekas scale
Assessment of white matter hyperintentisites severity on MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195816
Brief Title
A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leila DJABELKHIR
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
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.
Detailed Description
White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, white matter hyperintensities, computerized cognitive training, brain plasticity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison between experimental group and control group.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
computerized Cognitive training
Arm Type
Experimental
Arm Description
Experimental group will receive 1 year of a computer-based cognitive stimulation program.
Arm Title
MCI control group
Arm Type
No Intervention
Arm Description
The control group will receive a usual standard care without engagement in intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on Rey Auditory Verbal Learning test
Description
Assessment of verbal learning in episodic memory
Time Frame
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 Outcome Measure Information:
Title
Change on Fazekas scale
Description
Assessment of white matter hyperintentisites severity on MRI
Time Frame
Baseline assessment of WMH severity and evolution at 12 months immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie AR RIGAUD, Professor
Phone
00 33 1440835 03
Email
anne-sophie.rigaud@brc.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Leila LD DJABELKHIR, Neuropsychologist
Phone
00 33 6042305
Email
leila.djabelkhir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie AR RIGAUD, Professor
Organizational Affiliation
Broca University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
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