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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Cognitive Stimulation
Sponsored by
Leila DJABELKHIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MCI with WMH

    MCI without WMH

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Rey Auditory Verbal Learning test
    Assessment of verbal learning in episodic memory

    Secondary Outcome Measures

    Full Information

    First Posted
    June 14, 2017
    Last Updated
    June 20, 2017
    Sponsor
    Leila DJABELKHIR
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03195803
    Brief Title
    Cognitive Intervention in Mild Cognitive Impairment With or Without White Matter Hyperintensities
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    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 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparison, non-randomized single blind study
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MCI with WMH
    Arm Type
    Experimental
    Arm Description
    Computerized Cognitive Stimulation was administered to this group, twice a week.
    Arm Title
    MCI without WMH
    Arm Type
    Active Comparator
    Arm Description
    Computerized Cognitive Stimulation was administered to this group, twice a week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Computerized Cognitive Stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rey Auditory Verbal Learning test
    Description
    Assessment of verbal learning in episodic memory
    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

    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 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
    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

    Learn more about this trial

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

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