Neurostimulation for Cognitive Rehabilitation in Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)

Conditions
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Stroke, Cognitive Impairment, Cerebral Infarction

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dlPFC<br>Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex | Device: transcranial direct current stimulation<br> <br> * Other names: tdcs;|
| Experimental: CON<br>Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network | Device: transcranial direct current stimulation<br> <br> * Other names: tdcs;|
| Active Comparator: M1<br>Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex | Device: transcranial direct current stimulation<br> <br> * Other names: tdcs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive Function measured by Dysexecutive Questionnaire (DEX) |  | Change for executive functions at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 ] |