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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195803
Other study ID # LUS2WMH
Secondary ID
Status Completed
Phase N/A
First received June 14, 2017
Last updated June 20, 2017
Start date October 2015
Est. completion date April 2017

Study information

Verified date June 2017
Source Broca Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Leila DJABELKHIR

Outcome

Type Measure Description Time frame Safety issue
Primary Rey Auditory Verbal Learning test Assessment of verbal learning in episodic memory Baseline assessment, change from Baseline on Rey Auditory Verbal Learning test at 3 months immediately after intervention and at 3 months follow-up
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