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Cognitive Training in Stroke Patients

NCT ID: NCT03644290

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-02

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cognitive training

Semantic categorization training sessions

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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

Control condition

Five sessions of behavioral control condition with information and education

Group Type ACTIVE_COMPARATOR

Control Condition

Intervention Type BEHAVIORAL

Five sessions of active control information and education

Interventions

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Cognitive training

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

Intervention Type BEHAVIORAL

Control Condition

Five sessions of active control information and education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* vascular hemorrhages, stenosis, psychiatric problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

São Paulo State University

OTHER

Sponsor Role lead

Responsible Party

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Eliane Mioto

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eliane C Miotto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

Reference Type DERIVED
PMID: 35349186 (View on PubMed)

Miotto EC, Bazan PR, Batista AX, Conforto AB, Figueiredo EG, Martin MDGM, Avolio IB, Amaro E Jr, Teixeira MJ. Behavioral and Neural Correlates of Cognitive Training and Transfer Effects in Stroke Patients. Front Neurol. 2020 Sep 15;11:1048. doi: 10.3389/fneur.2020.01048. eCollection 2020.

Reference Type DERIVED
PMID: 33041987 (View on PubMed)

Other Identifiers

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Stroke Rehab

Identifier Type: -

Identifier Source: org_study_id