A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities

NCT ID: NCT03195816

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between experimental group and control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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computerized Cognitive training

Experimental group will receive 1 year of a computer-based cognitive stimulation program.

Group Type EXPERIMENTAL

Computerized Cognitive training

Intervention Type BEHAVIORAL

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.

MCI control group

The control group will receive a usual standard care without engagement in intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computerized Cognitive training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leila DJABELKHIR

OTHER

Sponsor Role lead

Responsible Party

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Leila DJABELKHIR

PhD candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne-Sophie AR RIGAUD, Professor

Role: PRINCIPAL_INVESTIGATOR

Broca University Hospital

Central Contacts

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Anne-Sophie AR RIGAUD, Professor

Role: CONTACT

00 33 1440835 03

Leila LD DJABELKHIR, Neuropsychologist

Role: CONTACT

00 33 6042305

Other Identifiers

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LUS3WMH

Identifier Type: -

Identifier Source: org_study_id

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