Cognitive Training in Stroke Patients

November 25, 2023 updated by: Eliane Mioto, São Paulo State University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403000
        • University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • vascular hemorrhages, stenosis, psychiatric problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline memory performance at 6 months
Time Frame: 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)
up to 24 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline everyday life activity performance at 6 months
Time Frame: up to 24 weeks of intervention
Generalization questionnaire (questions on difficulties in everyday memory total score 12)
up to 24 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

São Paulo State University

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: Eliane C Miotto, PhD, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 25, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stroke Rehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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