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Neurostimulation for Cognitive Rehabilitation in Stroke

NCT ID: NCT02315807

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Cognitive Impairment Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dlPFC

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

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

CON

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

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

M1

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

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation

Intervention Type DEVICE

Other Intervention Names

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tdcs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role collaborator

Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Suellen Marinho Andrade

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suellen Andrade, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraíba

Locations

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Suellen Andrade

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Suellen Andrade

Role: CONTACT

[email protected]

Facility Contacts

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Suellen Andrade

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26420269 (View on PubMed)

Other Identifiers

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NeuroCog001

Identifier Type: -

Identifier Source: org_study_id