Neurostimulation for Cognitive Rehabilitation in Stroke (NeuroCog)
December 4, 2015 updated by: Suellen Marinho Andrade, Federal University of Paraíba
Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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PB
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João Pessoa, PB, Brazil
- Recruiting
- Suellen Andrade
-
Contact:
- Suellen Andrade
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dlPFC
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex
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Other Names:
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Experimental: CON
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network
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Other Names:
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Active Comparator: M1
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Executive Function measured by Dysexecutive Questionnaire (DEX)
Time Frame: Change for executive functions at 4 weeks
|
Change for executive functions at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Verbal Fluency (Semantic Fluency Test)
Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
|
[ Time Frame: Baseline, Week 2 and Week 4 ]
|
|
Response inhibition (Go-no-go Test)
Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
|
[ Time Frame: Baseline, Week 2 and Week 4 ]
|
|
Executive function (Wechsler Intelligence Scale for Adults)
Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
|
[ Time Frame: Baseline, Week 2 and Week 4 ]
|
|
Memory (Rey Auditory Verbal Learning)
Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
|
[ Time Frame: Baseline, Week 2 and Week 4 ]
|
|
Processing Speed (Letter Comparison and Pattern Comparison Tasks)
Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
|
[ Time Frame: Baseline, Week 2 and Week 4 ]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Suellen Andrade, PhD, Federal University of Paraíba
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
December 9, 2014
First Submitted That Met QC Criteria
December 9, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
December 4, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuroCog001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.