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

Primary Purpose

Stroke, Cerebrovascular Disorders, Cerebral Infarction

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Constraint-Induced Movement Therapy
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suellen Andrade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

Active tdcs/M1

Active tdcs/Premotor

Sham tdcs

Arm Description

Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)

Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)

Sham tDCS and CIMT (constraint induced movement therapy)

Outcomes

Primary Outcome Measures

Functional Independence measured by Barthel Index

Secondary Outcome Measures

Spasticity (Modified Ashworth Scale)
Muscle strength (Medical Research Council Scale)

Full Information

First Posted
December 4, 2015
Last Updated
April 3, 2016
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02628561
Brief Title
Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Disorders, Cerebral Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tdcs/M1
Arm Type
Active Comparator
Arm Description
Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
Arm Title
Active tdcs/Premotor
Arm Type
Experimental
Arm Description
Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
Arm Title
Sham tdcs
Arm Type
Sham Comparator
Arm Description
Sham tDCS and CIMT (constraint induced movement therapy)
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy
Primary Outcome Measure Information:
Title
Functional Independence measured by Barthel Index
Time Frame
Change for functional independence at baseline and week 2
Secondary Outcome Measure Information:
Title
Spasticity (Modified Ashworth Scale)
Time Frame
Baseline and Week 2
Title
Muscle strength (Medical Research Council Scale)
Time Frame
Baseline and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Suellen Andrade
City
João Pessoa
State/Province
PB
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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