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

Not Applicable

• Conditions: Transcranial Direct Current Stimulation; Parkinson Disease; Electroencephalogram
• Interventions: Other: tDCS Active; Other: tDCS sham

• Registration Number: NCT04819061
• Lead Sponsor: Federal University of Paraíba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26
• Study Start: 2021-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	tDCS Active	In the group G1 will be administered: tDCS active + dual-task motor training
Sham group	tDCS sham	In the group G2 will be administered: tDCS sham + dual-task motor training

Primary Outcome Measures

Name	Time	Method
Functional Mobility measured using the Timed Up and Go test (Podsiadlo D, Richardson S, 1991)	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".