Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in EEG microstates
研究概览
简要总结
Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the disease. These deficits increase the risk of falls and reduce functional independence. Transcranial Direct Current Stimulation (ETCC) can be an attractive rehabilitation option in PD because it is a non-invasive and safe method that can modulate cortical excitability and improve motor and non-motor symptoms. One of the techniques to detect neurophysiological biomarkers associated with changes in the functional health of the brain and the effectiveness of this type of treatment is the analysis of microstates from the electroencephalogram (EEG). So, the objective of the present study is to investigate the effects of different assemblies of multifocal ETCC on the electrical brain activity represented by the EEG microstates and clinical characteristics in patients with PD.
详细描述
For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, between 40 and 75 years old, regardless of sex, recruited from the reference centers in neurology and physiotherapy in João Pessoa-PB. Participants will be randomized into three groups: Group 1 - ETCC over M1 + CPFDL; Group 2 - ETCC on M1 + APF; Group 3 - ETCC on M1. In each condition an initial baseline assessment (T0) will be performed after 16 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2). The evaluated outcomes will be: analysis of microstates and spectral analysis of frequencies by EEG; dual task capability with Timed Up and Go (TUG); executive function (Stroop test and verbal fluency test); motor aspects of daily life (MDS UPDRS II). For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and statistical significance considered at 5% (p ≤ 0.05).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
- •Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- •Regular antiparkinsonian pharmacological treatment;
- •Score higher than 24 or 18 (for participants with low education) in the Mini -Mental State Examination
- •Healthy Subjects inclusion criteria:
- •Ages: 40 - 75 years
- •Subjects who do not have self-report of neurodegenerative disorders
排除标准
- •Diagnosis of atypical parkinsonism;
- •Neurological comorbidities;
- •History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
- •DBS implantation - deep brain stimulation;
- •Patients missing two consecutive protocol sessions.
- •Healthy Subjects exclusion criteria:
- •History of epilepsy;
- •Metallic implants in the head;
- •Clinical evidence of brain injury.
结局指标
主要结局
Change in EEG microstates
时间窗: Baseline, after 6 weeks, and after 10 weeks
For the analysis of the EEG microstates the following temporal parameters will be considered: the average duration of each microstate; its frequency of occurrence; the fraction of the total recording time covered by each; the overall variation explained by each microstate and the probabilities of transition from one microstate to another. The brain electrical activity will be acquired through the BrainVision actiCHamp equipment using 32 Ag / AgCl electrodes that will be fixed according to the International 10-20 System, keeping the impedance below 10kΩ in silent condition and in eyes open states. and eyes closed. The output of the amplifier data will be directed to a computer with BrainVision Pycoder software to record the obtained records and the data will be processed using the BrainVision Analyzer.
次要结局
- Verbal Fluency Test(Baseline, after 6 weeks, and after 10 weeks)
- Spectral analysis of EEG frequencies(Baseline, after 6 weeks, and after 10 weeks)
- Dual Task(Baseline, after 6 weeks, and after 10 weeks)
- Motor aspects of daily life(Baseline, after 6 weeks, and after 10 weeks)
- Stroop test(Baseline, after 6 weeks, and after 10 weeks)
研究者
Suellen Marinho Andrade
Principal Investigator and Teacher
Federal University of Paraíba