Effect of Transcranial Direct Current Stimulation (tDCS) on a Virtual Reality Task in Individuals With Parkinson's Disease - Cross-sectional Project
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Motor skills improvement
研究概览
简要总结
A double-blinded randomized controlled trial will be conducted, and all the participants will undertake one session of non-immersive VR tasks and tDCS-active or tDCS-sham. It will be a cross-sectional protocol. All protocol will have the assessment of Autonomic Nervous System, through Heart Rate Variability Analysis.
详细描述
Study Design: A double-blinded randomized controlled trial will be conducted, and all the participants will undertake a non-immersive VR tasks and tDCS-active or tDCS-sham. It will be a cross-sectional protocol.
Participants and sampling: Participants will be recruited through referral by the coordinators of places or institutions who has patients available to participate in the state of São Paulo-Brazil.
Inclusion Criteria: Participants with idiopathic Parkinson's Disease, with diagnosis previously confirmed by a specialized doctor, will be included if they have the agreement to participate in the research by signing the informed consent form.
Exclusion Criteria: Participants will be excluded if they used a wheelchair, were unable to complete the procedures due to any reported fatigue or due to having to leave previously, and who could not stand without any kind of help, such as a carrier or walking aids.
Randomization Participants: Participants will be randomly allocated to either group 1 (tDCS-active and VR tasks) or group 2 (tDCS-sham and VR tasks). Randomization will be under the control of a blinded investigator who will be the only person allowed to manage the electronic security file of the randomization to assign the individuals. The investigator will be blind to the group in which the participant is allocated to.
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)
盲法说明
The participants, researchers and outcome assessors will remain blind throughout the study. To ensure proper blinding, the researcher responsible for that, will configurate the code of the tDCS device to sham or active before the proper application. It will be no difference between the devices for sham or active application of the tDCS.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's Disease with diagnosis previoulsy confirmed by a specialized doctor.
- •Agreement to participate in the research by signing the informed consent form.
- •Exclusion Criteria
- •Wheelchair use
- •Unable to complete the procedures due to any reported fatigue.
- •Unable to complete the procedures due having to leave previously.
- •Could not stand without any kind of help, such as a carrier or walking aids.
排除标准
- 未提供
结局指标
主要结局
Motor skills improvement
时间窗: 8 weeks.
The motor skills will be analyzed through the games developed specifically for analysis of motor skills, such as (interception skills, speed, accuracy and reaction time).
次要结局
- Heart Rate Variability(8 weeks.)
研究者
Talita Dias da Silva
Researcher
University of Sao Paulo