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Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
tDCS
Physiotherapy
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, rehabilitation, tDCS

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson -

Exclusion Criteria:

pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease

-

Sites / Locations

  • Applied Neuroscience Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Physiotherapy + anodal tDCS

Physiotherapy + sham tDCS

Arm Description

The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.

The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.

Outcomes

Primary Outcome Measures

Change From Unified Parkinson´s Disease Rating Scale - UPDRS
Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome)", as accurate and appropriate

Secondary Outcome Measures

Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation

Full Information

First Posted
June 11, 2013
Last Updated
May 14, 2015
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01877148
Brief Title
Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease
Official Title
Effects of Transcranial Direct Current Stimulation Associated With Physical Therapy on Motor Rehabilitation in Parkinson´s Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study aims to investigate the effect of transcranial direct current stimulation (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this way, this study will combine tDCS with physiotherapy in order to enhance the motor rehabilitation and the quality of life.
Detailed Description
12 patients were participated of this study.After screening to check the eligibility criteria and giving informed consent, they were randomized in two groups. All patients were submitted to a 10 therapeutic sessions that occurred 3 times per week. Before, immediately after and 1 month after the last session patients were submitted to an evaluation with the follow tests: Unified Parkinson´s Disease Rating Scale(UPDRS), Jebsen Taylor Test (JTT) and Parkinson's Disease Quality of Life (PDQL). Furthermore, before and after each session the patients were submitted to transcranial magnetic stimulation (TMS) to evaluate cortical excitability through motor threshold and motor evoked potential. In experimental sessions, the subjects always received physiotherapy with conventional techniques, the protocol followed the clinical practice guideline for physical therapy in Parkinson disease with the Royal Dutch Society Therapy. During tDCS protocol the patients seated in a comfortable chair with head and arm rests. Continuous current was applied using a pair of saline-soaked surface sponge electrodes (surface 35 cm2), the anode electrode was placed over the primary motor cortex and cathode above contralateral orbit. tDCS was applied of twice stimulation of 13 minutes with 20 minutes of interval between them and a current strength of 1mA. Sham tDCS was applied by current flow of 30s.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, rehabilitation, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy + anodal tDCS
Arm Type
Experimental
Arm Description
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Arm Title
Physiotherapy + sham tDCS
Arm Type
Sham Comparator
Arm Description
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
non invasive brain stimulation
Intervention Description
tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.
Primary Outcome Measure Information:
Title
Change From Unified Parkinson´s Disease Rating Scale - UPDRS
Description
Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome)", as accurate and appropriate
Time Frame
At baseline, after 1 month
Secondary Outcome Measure Information:
Title
Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
Time Frame
per sesssion: at baseline and after physical therapy
Other Pre-specified Outcome Measures:
Title
Change From Parkinson Disease Quality of Life - PDQL
Description
Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome)", as accurate and appropriate
Time Frame
at baseline, after 1 month
Title
Change From Jebsen-Taylor Hand Function Test - Jebsen Test
Description
The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function
Time Frame
At baseline, after 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson - Exclusion Criteria: pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kátia K Monte-Silva, PhD
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Study Director
Facility Information:
Facility Name
Applied Neuroscience Laboratory
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

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Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease

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