Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke

April 3, 2016 updated by: Suellen Marinho Andrade, Federal University of Paraíba
The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

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
    • PB
      • João Pessoa, PB, Brazil
        • Suellen Andrade

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Diagnosis of unilateral, non-recurring, subacute stroke
  • Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.

Exclusion Criteria:

  • Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits

  • tDCS 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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tdcs/M1
Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
Device: Transcranial direct current stimulation
Behavioral: Constraint-Induced Movement Therapy
Experimental: Active tdcs/Premotor
Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
Device: Transcranial direct current stimulation
Behavioral: Constraint-Induced Movement Therapy
Sham Comparator: Sham tdcs
Sham tDCS and CIMT (constraint induced movement therapy)
Device: Transcranial direct current stimulation
Behavioral: Constraint-Induced Movement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Independence measured by Barthel Index
Time Frame: Change for functional independence at baseline and week 2
Change for functional independence at baseline and week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Spasticity (Modified Ashworth Scale)
Time Frame: Baseline and Week 2
Baseline and Week 2
Muscle strength (Medical Research Council Scale)
Time Frame: Baseline and Week 2
Baseline and Week 2

Collaborators and Investigators

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

Sponsor

Federal University of Paraíba

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

January 1, 2016

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 3, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tdcstroke

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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