Back to resultsCognitive Training in Stroke Patients
Primary Purpose
Vascular Diseases
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive training
Control Condition
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases focused on measuring vascular ischemic lesion
Eligibility Criteria
Inclusion Criteria:
- people with chronic vascular ischemic lesions (more than 6 months)
Exclusion Criteria:
- vascular hemorrhages, stenosis, psychiatric problems
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive training
Control condition
Arm Description
Semantic categorization training sessions
Five sessions of behavioral control condition with information and education
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from baseline everyday life activity performance at 6 months
Generalization questionnaire (questions on difficulties in everyday memory total score 12)
Full Information
NCT ID
NCT03644290
First Posted
August 16, 2018
Last Updated
May 9, 2022
Sponsor
São Paulo State University
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03644290
Brief Title
Cognitive Training in Stroke Patients
Official Title
Neural Correlates and Functional Connectivity Associated With Cognitive Memory Training in Patients With Cerebral Ischemic Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2015 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
São Paulo State University
Collaborators
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to investigate the behavioral effects, neural correlates and functional connectivity of cognitive training in patients with stroke
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
vascular ischemic lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
Semantic categorization training sessions
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
Five sessions of behavioral control condition with information and education
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
Five sessions of semantic strategy training and face-name association training
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Five sessions of active control information and education
Primary Outcome Measure Information:
Title
Change from baseline memory performance at 6 months
Description
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 Outcome Measure Information:
Title
Change from baseline everyday life activity performance at 6 months
Description
Generalization questionnaire (questions on difficulties in everyday memory total score 12)
Time Frame
up to 24 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
people with chronic vascular ischemic lesions (more than 6 months)
Exclusion Criteria:
vascular hemorrhages, stenosis, psychiatric problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliane C Miotto, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35349186
Citation
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.
Results Reference
derived
PubMed Identifier
33041987
Citation
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.
Results Reference
derived
Learn more about this trial
Cognitive Training in Stroke Patients
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