Clinical trial NCT02315807: Neurostimulation for Cognitive Rehabilitation in Stroke
Official title: Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stroke
Cognitive Impairment
Cerebral Infarction
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio Grande do Norte
First posted: 2014-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Executive Function measured by Dysexecutive Questionnaire (DEX)
timeFrame: Change for executive functions at 4 weeks
Secondary outcomes:
measure: Verbal Fluency (Semantic Fluency Test)
timeFrame: [ Time Frame: Baseline, Week 2 and Week 4 ]
measure: Response inhibition (Go-no-go Test)
timeFrame: [ Time Frame: Baseline, Week 2 and Week 4 ]
measure: Executive function (Wechsler Intelligence Scale for Adults)
timeFrame: [ Time Frame: Baseline, Week 2 and Week 4 ]
measure: Memory (Rey Auditory Verbal Learning)
timeFrame: [ Time Frame: Baseline, Week 2 and Week 4 ]
measure: Processing Speed (Letter Comparison and Pattern Comparison Tasks)
timeFrame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Andrade
state: PB
Study officials:
affiliation: Federal University of Paraíba
name: Suellen Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrade SM, Fernandez-Calvo B, Boggio PS, de Oliveira EA, Gomes LF, Pinheiro Junior JE, Rodrigues RM, de Almeida NL, Moreira GM, Alves NT. Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial. Trials. 2015 Sep 29;16:435. doi: 10.1186/s13063-015-0945-1.