Neurostimulation for Cognitive Rehabilitation in Stroke

Stroke Clinical Trial

— NeuroCog  

Official title:

Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02315807
• Other study ID #: NeuroCog001
• 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

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognition Disorders
• Cognitive Impairment
• Stroke

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