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Completed

NCT Number: NCT02628561

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

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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Suellen Andrade

João Pessoa, Paraíba, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Constraint-induced movement therapy

Behavioral

Primary outcomes

  1. Functional Independence measured by Barthel Index

    Time frame: Change for functional independence at baseline and week 2

Secondary outcomes

  1. Spasticity (Modified Ashworth Scale)

    Time frame: Baseline and Week 2

  2. Muscle strength (Medical Research Council Scale)

    Time frame: Baseline and Week 2

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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