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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03644290
Other study ID # Stroke Rehab
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2, 2015
Est. completion date December 31, 2023

Study information

Verified date November 2023
Source São Paulo State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate the behavioral effects, neural correlates and functional connectivity of cognitive training in patients with stroke


Description:

The study will investigate the effects of two cognitive training strategies on behavior, neural correlates and functional connectivity of patients with vascular lesions. The first strategy is associated to the ability to apply efficient organizational semantic category strategy to a list of words. This strategy will be trained in activities similar to everyday life activities. There will be in total 5 sessions, two for measuring the generalization effects before and after training and three sessions to apply the semantic strategy in order to improve encoding and episodic memory performance. The second strategy is related to the ability to remember face-names and the strategy will involve the identification of a salient face feature, creation of a nickname and association of the nickname to the real name. There will be 5 sessions in total, two for measuring the generalization effects before and after training and three sessions to apply the face-name association strategy in order to improve encoding and episodic memory performance. These two cognitive training procedures will be carried out in two separate moments. Before and after each procedure all participants will be examined by functional MRI during resting state and during a active task using a memory encoding paradigm. The same procedure will be carried out with normal control participants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - people with chronic vascular ischemic lesions (more than 6 months) Exclusion Criteria: - vascular hemorrhages, stenosis, psychiatric problems

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive training
Five sessions of semantic strategy training and face-name association training
Control Condition
Five sessions of active control information and education

Locations

Country Name City State
Brazil University of Sao Paulo São Paulo Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
São Paulo State University University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline memory performance at 6 months Hopkins Verbal Learning Test (episodic memory test total immediate score 48 and delayed score12) and fMRI active task (news recall immediate and delayed score 12) up to 24 weeks after intervention
Secondary Change from baseline everyday life activity performance at 6 months Generalization questionnaire (questions on difficulties in everyday memory total score 12) up to 24 weeks of intervention
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