Cerebral Infarction, Cognitive Impairment, Stroke
Conditions
Brief summary
Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.
Interventions
DEVICEtranscranial direct current stimulation
Sponsors
Universidade Federal do Rio Grande do Norte
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Ischaemic chronic stroke * Mild/Moderate Cognitive impairment * Informed consent
Exclusion criteria
* National Institute of Health Stroke Scale (NIHSS) ≥ 16 points * Severe cognitive comorbidities (dementia, depression) * transcranial direct current stimulation criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Executive Function measured by Dysexecutive Questionnaire (DEX) | Change for executive functions at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Verbal Fluency (Semantic Fluency Test) | [ Time Frame: Baseline, Week 2 and Week 4 ] |
| Response inhibition (Go-no-go Test) | [ Time Frame: Baseline, Week 2 and Week 4 ] |
| Executive function (Wechsler Intelligence Scale for Adults) | [ Time Frame: Baseline, Week 2 and Week 4 ] |
| Memory (Rey Auditory Verbal Learning) | [ Time Frame: Baseline, Week 2 and Week 4 ] |
| Processing Speed (Letter Comparison and Pattern Comparison Tasks) | [ Time Frame: Baseline, Week 2 and Week 4 ] |
Countries
Brazil
Contacts
Primary ContactSuellen Andrade
Outcome results
None listed