Neurostimulation for Cognitive Rehabilitation in Stroke

Phase 2

• Conditions: Stroke; Cerebral Infarction; Cognitive Impairment
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT02315807
• Lead Sponsor: Federal University of Paraíba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-12
• Status Verified: 2015-12
• Study Start: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07
• Primary Completion: 2016-03
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dlPFC	transcranial direct current stimulation	Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex
CON	transcranial direct current stimulation	Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network
M1	transcranial direct current stimulation	Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Primary Outcome Measures

Name	Time	Method
Executive Function measured by Dysexecutive Questionnaire (DEX)	Change for executive functions at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Verbal Fluency (Semantic Fluency 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 ]
Response inhibition (Go-no-go Test)	[ Time Frame: Baseline, Week 2 and Week 4 ]

Trial Locations

Locations (1)

Suellen Andrade; 🇧🇷 João Pessoa, PB, Brazil