Clinical trial NCT03644290: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vascular Diseases
Keywords: vascular ischemic lesion
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2018-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* vascular hemorrhages, stenosis, psychiatric problems

Primary outcomes:
measure: Change from baseline memory performance at 6 months
timeFrame: up to 24 weeks after intervention
Secondary outcomes:
measure: Change from baseline everyday life activity performance at 6 months
timeFrame: up to 24 weeks of intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Eliane C Miotto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.