Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients

June 12, 2019 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre

Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Federal University of Health Sciences of Porto Alegre

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tDCS
Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.
Device: tDCS
Transcranial direct current stimulation (tDCS)
Active Comparator: rTMS
Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.
Device: TMS
Transcranial magnetic stimulation
Experimental: 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.
Device: tDCS + TMS
Association between tDCS and TMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Motor Function by means of the Wolf Motor Function Test
Time Frame: change from pre to post (at least 10 days)
change from pre to post (at least 10 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Grip strength via hand dynamometer
Time Frame: change from pre to post (at least 10 days)
change from pre to post (at least 10 days)
Manual Dexterity by means of the Box and Block Test
Time Frame: change from pre to post (at least 10 days)
change from pre to post (at least 10 days)
Quality of Life by means of the Stroke Impact Scale
Time Frame: change from pre to post (at least 10 days)
change from pre to post (at least 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

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

June 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPG-2016

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.

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