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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
Leila DJABELKHIR
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

    First Posted
    June 14, 2017
    Last Updated
    June 20, 2017
    Sponsor
    Leila DJABELKHIR
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    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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