跳至主要内容
临床试验/NCT04819061
NCT04819061Unknown不适用

Predicting Outcomes From tDCS Intervention in Parkinson' Disease Using Electroencephalographic Biomarkers and Machine Learning Approach: the PREDICT Study Protocol

Federal University of Paraíba0 个研究点目标入组 56 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
56
主要终点
Functional Mobility measured using the Timed Up and Go test (Podsiadlo D, Richardson S, 1991)

研究概览

简要总结

Parkinson's disease (PD) is a progressive and disabling neurodegenerative disease, clinically characterized by motor and non-motor symptoms. The potential of the "Transcranial direct current stimulation" (tDCS) for symptomatic improvement in these patients has been demonstrated, but the factors associated with the best therapeutic response are not known. The electroencephalogram (EEG) is considered as a diagnostic and prognostic biomarker of PD, and has been used in recent studies associated with machine-learning methods to identify predictors of responses in neurological and psychiatric conditions. Using connectivity-based prediction and machine-learning, the investigators intend to identify and compare characteristics related to baseline resting EEG between PD responders and non-responders to tDCS treatment.

The recruited participants will be randomized to treatment with active tDCS associated with dual-task motor therapy or motor therapy with visual cues. A resting-state electroencephalography (EEG) will be recorded prior to the start of the treatment. The investigators will determine clinical improvement labels used for machine learning classification, in baseline and posttreatment assessments and will use three different methods to categorize the data into two classes (low or high improvement): Support Vector Machine (SVM), Linear Discriminant Analysis (LDA) and Extreme Learning Machine (ELM). The functional label will be based on the Timed Up and Go Test recorded at baseline and posttreament of tDCS treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic Parkinson's disease by a neurologist based on Parkinson's Disease Society Brain Bank (PDSBB) criteria (Hughes et al.,1992)
  • Disease staging between 1.5 and 3, according to the modified Hoehn and Yahr scale (Hoehn and Yahr, 1967)
  • Regular pharmacological treatment with levodopa (equivalent dose > 300mg) or taking antiparkinsonian medication such as anticholinergics, selegiline, dopamine agonists (amantadine) and COMT (catechol-O-methyl transferase) inhibitors
  • Score of more than 24 points on the Mini-Mental State Examination (Folstein et al., 1975)

排除标准

  • Associated neurological, musculoskeletal and/or cardiorespiratory diseases that could compromise gait;
  • alcohol or substance abuse disorders;
  • Deep brain stimulation implant;
  • History of brain trauma or neurological disease that would interfere with study procedures.

结局指标

主要结局

Functional Mobility measured using the Timed Up and Go test (Podsiadlo D, Richardson S, 1991)

时间窗: 4 weeks

The functional mobility will be measured using the Timed Up and Go test to stand up from a chair at the command: "Walk 3 meters, walk along a demarcated course, turn around and walk back to the chair, then sit down".

次要结局

未报告次要终点

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suellen Marinho Andrade

Principal Investigator and Professor

Federal University of Paraíba

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