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

June 20, 2017 updated by: Leila DJABELKHIR

Evaluation of Differential Effects of a Computer-based-cognitive Intervention on Cognition Among Elderly With Mild Cognitive Impairment With and Without White Matter Hyperintensities: A Comparative Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCI with WMH
Computerized Cognitive Stimulation was administered to this group, twice a week.
Behavioral: 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.
Active Comparator: MCI without WMH
Computerized Cognitive Stimulation was administered to this group, twice a week.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rey Auditory Verbal Learning test
Time Frame: Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up
Assessment of verbal learning in episodic memory
Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leila DJABELKHIR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUS2WMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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