Neurostimulation for Cognitive Rehabilitation in Stroke "NeuroCog"

Recruiting

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Other Names: tDCS
    ARM 1: Kind: Experimental
    Label: dlPFC
    Description: Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex
    ARM 2: Kind: Experimental
    Label: CON
    Description: Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network
    ARM 3: Kind: Experimental
    Label: M1
    Description: Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Executive Function measured by Dysexecutive Questionnaire (DEX) Change for executive functions at 4 weeks No
Secondary Verbal Fluency (Semantic Fluency Test) [ Time Frame: Baseline, Week 2 and Week 4 ] No
Secondary Response inhibition (Go-no-go Test) [ Time Frame: Baseline, Week 2 and Week 4 ] No
Secondary Executive function (Wechsler Intelligence Scale for Adults) [ Time Frame: Baseline, Week 2 and Week 4 ] No
Secondary Memory (Rey Auditory Verbal Learning) [ Time Frame: Baseline, Week 2 and Week 4 ] No
Secondary Processing Speed (Letter Comparison and Pattern Comparison Tasks) [ Time Frame: Baseline, Week 2 and Week 4 ] No

Sponsors