A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
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|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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Computerized Cognitive training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Comparison between experimental group and control group.|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
Experimental: computerized Cognitive training
Experimental group will receive 1 year of a computer-based cognitive stimulation program.
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.
No Intervention: MCI control group
The control group will receive a usual standard care without engagement in intervention
- 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
- 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
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): NCT03195816
|Contact: Anne-Sophie AR RIGAUD, Professor||00 33 1440835 email@example.com|
|Contact: Leila LD DJABELKHIR, Neuropsychologist||00 33 firstname.lastname@example.org|
|Principal Investigator:||Anne-Sophie AR RIGAUD, Professor||Broca University Hospital|