Cognitive Training in Stroke Patients

Sponsor

São Paulo State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03644290

Collaborator

University of Sao Paulo (Other)

Enrollment

Location

Arms

107.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases	Behavioral: Cognitive training Behavioral: Control Condition	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Neural Correlates and Functional Connectivity Associated With Cognitive Memory Training in Patients With Cerebral Ischemic Lesions

Actual Study Start Date :

Jan 2, 2015

Actual Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive training Semantic categorization training sessions	Behavioral: Cognitive training Five sessions of semantic strategy training and face-name association training
Active Comparator: Control condition Five sessions of behavioral control condition with information and education	Behavioral: Control Condition Five sessions of active control information and education

Arm

Intervention/Treatment

Experimental: Cognitive training

Semantic categorization training sessions

Behavioral: Cognitive training

Five sessions of semantic strategy training and face-name association training

Active Comparator: Control condition

Five sessions of behavioral control condition with information and education

Behavioral: Control Condition

Five sessions of active control information and education

Outcome Measures

Primary Outcome Measures

Change from baseline memory performance at 6 months [up to 24 weeks after intervention]
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)

Secondary Outcome Measures

Change from baseline everyday life activity performance at 6 months [up to 24 weeks of intervention]
Generalization questionnaire (questions on difficulties in everyday memory total score 12)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

people with chronic vascular ischemic lesions (more than 6 months)

Exclusion Criteria:

vascular hemorrhages, stenosis, psychiatric problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo	São Paulo	Sao Paulo	Brazil	05403000

Sponsors and Collaborators

São Paulo State University
University of Sao Paulo

Investigators

Principal Investigator: Eliane C Miotto, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eliane Mioto, Principal investigator, São Paulo State University

ClinicalTrials.gov Identifier:

NCT03644290

Other Study ID Numbers:

Stroke Rehab

First Posted:

Aug 23, 2018

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eliane Mioto, Principal investigator, São Paulo State University

vascular ischemic lesion

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of May 10, 2022