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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195816
Recruitment Status : Unknown
Verified June 2017 by Leila DJABELKHIR, Broca Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leila DJABELKHIR, Broca Hospital

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date June 22, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Change on Rey Auditory Verbal Learning test [ 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 ]
Assessment of verbal learning in episodic memory
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Change on Fazekas scale [ Time Frame: Baseline assessment of WMH severity and evolution at 12 months immediately after intervention ]
Assessment of white matter hyperintentisites severity on MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparison between experimental group and control group.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • Experimental: computerized Cognitive training
    Experimental group will receive 1 year of a computer-based cognitive stimulation program.
    Intervention: Behavioral: Computerized Cognitive training
  • No Intervention: MCI control group
    The control group will receive a usual standard care without engagement in intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195816
Other Study ID Numbers  ICMJE LUS3WMH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leila DJABELKHIR, Broca Hospital
Study Sponsor  ICMJE Leila DJABELKHIR
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Sophie AR RIGAUD, Professor Broca University Hospital
PRS Account Broca Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP