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临床试验/NCT01877148
NCT01877148已完成2 期

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

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Change From Unified Parkinson´s Disease Rating Scale - UPDRS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change From Unified Parkinson´s Disease Rating Scale - UPDRS

时间窗: 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

次要结局

  • Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation(per sesssion: at baseline and after physical therapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kátia Monte-Silva

Doctor

Universidade Federal de Pernambuco

研究点 (2)

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