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Neurostimulation for Cognitive Rehabilitation in Stroke (NeuroCog)

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ClinicalTrials.gov Identifier: NCT02315807
Recruitment Status : Unknown
Verified December 2015 by Suellen Marinho Andrade, Federal University of Paraíba.
Recruitment status was:  Recruiting
First Posted : December 12, 2014
Last Update Posted : December 7, 2015
Sponsor:
Collaborator:
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Suellen Marinho Andrade, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Stroke Cognitive Impairment Cerebral Infarction Device: transcranial direct current stimulation Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
Study Start Date : December 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: dlPFC
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex
Device: transcranial direct current stimulation
Other Name: tdcs

Experimental: CON
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network
Device: transcranial direct current stimulation
Other Name: tdcs

Active Comparator: M1
Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex
Device: transcranial direct current stimulation
Other Name: tdcs




Primary Outcome Measures :
  1. Executive Function measured by Dysexecutive Questionnaire (DEX) [ Time Frame: Change for executive functions at 4 weeks ]

Secondary Outcome Measures :
  1. Verbal Fluency (Semantic Fluency Test) [ Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ] ]
  2. Response inhibition (Go-no-go Test) [ Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ] ]
  3. Executive function (Wechsler Intelligence Scale for Adults) [ Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ] ]
  4. Memory (Rey Auditory Verbal Learning) [ Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ] ]
  5. Processing Speed (Letter Comparison and Pattern Comparison Tasks) [ Time Frame: [ Time Frame: Baseline, Week 2 and Week 4 ] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315807


Contacts
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Contact: Suellen Andrade suellenandrade@gmail.com

Locations
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Brazil
Suellen Andrade Recruiting
João Pessoa, PB, Brazil
Contact: Suellen Andrade         
Sponsors and Collaborators
Federal University of Paraíba
Universidade Federal do Rio Grande do Norte
Investigators
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Principal Investigator: Suellen Andrade, PhD Federal University of Paraíba

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Suellen Marinho Andrade, PhD, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02315807     History of Changes
Other Study ID Numbers: NeuroCog001
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Stroke
Infarction
Cognitive Dysfunction
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Infarction
Brain Ischemia