Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities

NCT ID: NCT03195803

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

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-30

Brief Summary

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This is a non-pharmacological study evaluating the differential effects of a computerized cognitive stimulation program according to the existence or not of white matter hyperintensities in elderly with mild cognitive impairment.

Detailed Description

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White matter hyperintensities (WMH) are increasingly recognized as a factor determining the heterogeneity of Mild Cognitive Impairment (MCI) and have been associated to executive and processing speed impairment. Cognitive interventions in MCI remain quite limited for these MCI with vascular profile and studies often distinguish patients by clinical subtypes rather than brain profile before an intervention. Considering magnetic resonance imaging (MRI) data, this study investigated the effects of a computer-based cognitive stimulation (CCS) program on MCI with WMH compared to MCI without WMH.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison, non-randomized single blind study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MCI with WMH

Computerized Cognitive Stimulation was administered to this group, twice a week.

Group Type EXPERIMENTAL

Computerized Cognitive Stimulation

Intervention Type BEHAVIORAL

All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.

MCI without WMH

Computerized Cognitive Stimulation was administered to this group, twice a week.

Group Type ACTIVE_COMPARATOR

Computerized Cognitive Stimulation

Intervention Type BEHAVIORAL

All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.

Interventions

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Computerized Cognitive Stimulation

All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program 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 white matter hyperintensities
* MRI 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 abuse
* Sensory and/or motor deficit affecting the use of a tablet
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

Other Identifiers

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LUS2WMH

Identifier Type: -

Identifier Source: org_study_id

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