Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

NCT ID: NCT02817867

Last Updated: 2019-06-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery.

The aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery after stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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tDCS

Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

Transcranial direct current stimulation (tDCS)

rTMS

Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.

Group Type ACTIVE_COMPARATOR

TMS

Intervention Type DEVICE

Transcranial magnetic stimulation

tDCS + rTMS

Patients who will be treated with the association between Transcranial direct-current stimulation (tDCS) and magnetic brain stimulation (rTMS), in the ipsilesional and contralesional motor cortex, respectively.

Group Type EXPERIMENTAL

tDCS + TMS

Intervention Type DEVICE

Association between tDCS and TMS.

Interventions

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tDCS

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

TMS

Transcranial magnetic stimulation

Intervention Type DEVICE

tDCS + TMS

Association between tDCS and TMS.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition);
* Ability to reach 60 degrees in the shoulder flexion
* Ability to completely extend the fingers in the affected upper limb;
* Minimal cognitive ability to understand commands;
* No current use of antiepileptic drugs for seizures.

Exclusion Criteria

* Painful shoulder, adhesive capsulitis or glenohumeral subluxation;
* Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Aline de Souza Pagnussat

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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APPG-2016

Identifier Type: -

Identifier Source: org_study_id

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