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Neurostimulation for Cognitive Rehabilitation in Stroke (NeuroCog)

Primary Purpose

Stroke, Cognitive Impairment, Cerebral Infarction

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Suellen AndradeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

dlPFC

CON

Arm Description

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Outcomes

Primary Outcome Measures

Executive Function measured by Dysexecutive Questionnaire (DEX)

Secondary Outcome Measures

Verbal Fluency (Semantic Fluency Test)

Response inhibition (Go-no-go Test)

Executive function (Wechsler Intelligence Scale for Adults)

Memory (Rey Auditory Verbal Learning)

Processing Speed (Letter Comparison and Pattern Comparison Tasks)

Full Information

NCT ID

NCT02315807

First Posted

December 9, 2014

Last Updated

December 4, 2015

Sponsor

Federal University of Paraíba

Collaborators

Universidade Federal do Rio Grande do Norte

1. Study Identification

Unique Protocol Identification Number

NCT02315807

Brief Title

Neurostimulation for Cognitive Rehabilitation in Stroke

Acronym

NeuroCog

Official Title

Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Paraíba

Collaborators

Universidade Federal do Rio Grande do Norte

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cognitive Impairment, Cerebral Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dlPFC

Arm Type

Experimental

Arm Description

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex

Arm Title

CON

Arm Type

Experimental

Arm Description

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network

Arm Title

Arm Type

Active Comparator

Arm Description

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Other Intervention Name(s)

tdcs

Primary Outcome Measure Information:

Title

Executive Function measured by Dysexecutive Questionnaire (DEX)

Time Frame

Change for executive functions at 4 weeks

Secondary Outcome Measure Information:

Title

Verbal Fluency (Semantic Fluency Test)

Time Frame