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Active, not recruitingNCT03644290Updated Nov 28, 2023

Cognitive Training in Stroke Patients

An interventional study of Cognitive training and Control Condition in Vascular Diseases, sponsored by São Paulo State University. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by São Paulo State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Jan 2015, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Vascular Diseases

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Keywords

  • vascular ischemic lesion
03

In context

Vascular Diseases

694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.

This study's enrollment of 30 is below the median of 96 across 419 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

São Paulo State University is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • vascular hemorrhages, stenosis, psychiatric problems
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Cognitive training

    Semantic categorization training sessions

    Behavioral: Cognitive training

  • Active comparator
    Control condition

    Five sessions of behavioral control condition with information and education

    Behavioral: Control Condition

Interventions

  • BehavioralCognitive training

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

  • BehavioralControl Condition

    Five sessions of active control information and education

06

What researchers measure

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)

    Time frame: up to 24 weeks after intervention

Secondary outcomes

  1. Change from baseline everyday life activity performance at 6 months

    Generalization questionnaire (questions on difficulties in everyday memory total score 12)

    Time frame: up to 24 weeks of intervention

07

Study locations

1 site
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References and documents

Publications

  • 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. PubMed 35349186 ↗
  • 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. Erratum In: Front Neurol. 2021 Nov 03;12:785008. doi: 10.3389/fneur.2021.785008. PubMed 33041987 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Feb 2018, 36 months.

Of 103 non-industry interventional studies with no phase under Vascular Diseases, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 57. This study's 36 months is above that.

Counting every sponsor, half of 147 studies reached it within 33 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2018
First posted
Aug 23, 2018
StartActual
Jan 2, 2015
Primary completionActual
Feb 1, 2018
CompletionEst.
Dec 31, 2023
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03644290
Lead sponsor
São Paulo State University
Responsible party
Eliane Mioto (Principal investigator, São Paulo State University) — Principal investigator
First posted
Aug 23, 2018
Start date
Jan 2, 2015
Primary completion
Feb 1, 2018
Completion
Dec 31, 2023 (estimated)
Last update
Nov 28, 2023

Study contacts

Eliane C Miotto, PhD
principal investigator · University of Sao Paulo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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