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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02315807
Other study ID # NeuroCog001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 9, 2014
Last updated December 4, 2015
Start date December 2015
Est. completion date July 2016

Study information

Verified date December 2015
Source Federal University of Paraíba
Contact Suellen Andrade
Email suellenandrade@gmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

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


Intervention

Device:
transcranial direct current stimulation


Locations

Country Name City State
Brazil Suellen Andrade João Pessoa PB

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Paraíba Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description 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
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