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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04819061
Other study ID # EEGtDCS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information

Verified date March 2021
Source Federal University of Paraíba
Contact Suellen Andrade
Phone 986046032
Email suellenandrade@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date December 31, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
tDCS Active
This group will undergo the motor training and active tDCS. Will be performed 12 sessions in three sessions per week for 30 minutes. Participants will undergo an electroencephalogram before starting the clinical trial. The duration between this baseline EEG and entry into the clinical trial that will assess the effectiveness of tDCS will be two weeks. We will determine the clinical improvement labels used for machine learning classification based on data obtained during the clinical trial (baseline and post-treatment assessments), according to procedures conducted in similar studies.
tDCS sham
This group will undergo the motor training and tDCS sham. Will be performed 12 sessions in three sessions per week for 30 minutes. Participants will undergo an electroencephalogram before starting the clinical trial. The duration between this baseline EEG and entry into the clinical trial that will assess the effectiveness of tDCS will be two weeks. We will determine the clinical improvement labels used for machine learning classification based on data obtained during the clinical trial (baseline and post-treatment assessments), according to procedures conducted in similar studies.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Paraíba Universidade Federal do Rio Grande do Norte

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Mobility measured using the Timed Up and Go test (Podsiadlo D, Richardson S, 1991) 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". 4 weeks
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