Neurostimulation for Cognitive Rehabilitation in Stroke

NCT02315807 | Unknown Phase 2

• 1 other identifier: NeuroCog001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Impairment; Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Executive Function measured by Dysexecutive Questionnaire (DEX)

  Change for executive functions at 4 weeks

Secondary Outcomes (5)

• Verbal Fluency (Semantic Fluency Test)

  [ Time Frame: Baseline, Week 2 and Week 4 ]

• Response inhibition (Go-no-go Test)

  [ Time Frame: Baseline, Week 2 and Week 4 ]

• Executive function (Wechsler Intelligence Scale for Adults)

  [ Time Frame: Baseline, Week 2 and Week 4 ]

• Memory (Rey Auditory Verbal Learning)

  [ Time Frame: Baseline, Week 2 and Week 4 ]

• Processing Speed (Letter Comparison and Pattern Comparison Tasks)

  [ Time Frame: Baseline, Week 2 and Week 4 ]

Study Arms (3)

dlPFC

EXPERIMENTAL

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex

Device: transcranial direct current stimulation

CON

EXPERIMENTAL

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network

Device: transcranial direct current stimulation

M1

ACTIVE COMPARATOR

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Also known as: tdcs

CON; M1; dlPFC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ischaemic chronic stroke
• Mild/Moderate Cognitive impairment
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Paraíba: lead
• Universidade Federal do Rio Grande do Norte: collaborator

Study Sites (1)

Suellen Andrade

João Pessoa, Paraíba, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 26420269 DERIVED

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Cerebral Infarction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suellen Andrade, PhD

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen Andrade

CONTACT

suellenandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

BR (1)