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NCT Number: NCT01877148

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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Treatment and study plan

tDCS

Device

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.

Other names: non invasive brain stimulation

Physiotherapy

Behavioral

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 outcomes

  1. Change From Unified Parkinson´s Disease Rating Scale - UPDRS

    Time frame: At baseline, after 1 month

    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 outcomes

  1. Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation

    Time frame: per sesssion: at baseline and after physical therapy

Other outcomes

  1. Change From Parkinson Disease Quality of Life - PDQL

    Time frame: at baseline, after 1 month

    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

  2. Change From Jebsen-Taylor Hand Function Test - Jebsen Test

    Time frame: At baseline, after 1 month

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation Associated With Physical Therapy on Motor Rehabilitation in Parkinson´s Disease Patients

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2013
Registry last updated
May 15, 2015

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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