Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Cognitive Intervention in Mild Cognitive Impairment With or Without 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: NCT03195803
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leila DJABELKHIR, Broca Hospital

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Computerized Cognitive Stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison, non-randomized single blind study
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : October 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195803


Sponsors and Collaborators
Leila DJABELKHIR
Investigators
Layout table for investigator information
Principal Investigator: Anne-Sophie AR RIGAUD, Professor Broca University Hospital

Layout table for additonal information
Responsible Party: Leila DJABELKHIR, PhD candidate, Broca Hospital
ClinicalTrials.gov Identifier: NCT03195803    
Other Study ID Numbers: LUS2WMH
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders