NCT03644290

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

August 16, 2018

Last Update Submit

November 25, 2023

Conditions

Keywords

vascular ischemic lesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline everyday life activity performance at 6 months

    up to 24 weeks of intervention

Study Arms (2)

Cognitive training

EXPERIMENTAL

Semantic categorization training sessions

Behavioral: Cognitive training

Control condition

ACTIVE COMPARATOR

Five sessions of behavioral control condition with information and education

Behavioral: Control Condition

Interventions

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

Cognitive training

Five sessions of active control information and education

Control condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • vascular hemorrhages, stenosis, psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Vascular Diseases

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eliane C Miotto, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 23, 2018

Study Start

January 2, 2015

Primary Completion

February 1, 2018

Study Completion

December 31, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations