Vascular DiseasesNCT03644290
Cognitive Training in Stroke Patients
A study testing Cognitive training in people with Vascular Diseases, run by São Paulo State University at 1 site in Brazil.
Trial summary
The study aims to investigate the behavioral effects, neural correlates and functional connectivity of cognitive training in patients with stroke Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2015to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- people with chronic vascular ischemic lesions (more than 6 months)
Who cannot join
- vascular hemorrhages, stenosis, psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Vascular Diseases
- Being tested
- Cognitive training, Control Condition
- Keywords
- vascular ischemic lesion
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Five sessions of semantic strategy training and face-name association training
Control ConditionBehavioural
Five sessions of active control information and education
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Semantic categorization training sessions Receives: Behavioral: Cognitive training |
| Control condition | Active comparator | Five sessions of behavioral control condition with information and education Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: up to 24 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start2 Jan 2015
- Primary completion1 Feb 2018
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Eliane Mioto, São Paulo State University
- Investigators
- Eliane C Miotto, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644290
- Sponsor's protocol ID
- Stroke Rehab
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35349186Miotto 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.
PubMed 33041987
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates and Functional Connectivity Associated With Cognitive Memory Training in Patients With Cerebral Ischemic Lesions
- ClinicalTrials.gov ID
- NCT03644290
- Acronym / sponsor ID
- Stroke Rehab
- Conditions
- Vascular Diseases
- Keywords
- vascular ischemic lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Behavioral: Cognitive trainingSemantic categorization training sessions |
| Control condition | Active comparator | Behavioral: Control ConditionFive sessions of behavioral control condition with information and education |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- people with chronic vascular ischemic lesions (more than 6 months)
Key exclusion criteria (1 listed)
- vascular hemorrhages, stenosis, psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingFive sessions of semantic strategy training and face-name association training | Behavioural | Cognitive training |
| Control ConditionFive sessions of active control information and education | Behavioural | Control condition |
Primary outcome
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)
1 secondary outcome
Change from baseline everyday life activity performance at 6 months
Time frame: up to 24 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 35349186Gibson 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.
- Derived from this study: PubMed 33041987Miotto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane C Miotto, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Vascular Diseases, run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline memory performance at 6 months (time frame: up to 24 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.