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

Primary Purpose

Parkinson Disease, Electroencephalogram, Transcranial Direct Current Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS Active
tDCS sham
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active group

    Sham group

    Arm Description

    In the group G1 will be administered: tDCS active + dual-task motor training

    In the group G2 will be administered: tDCS sham + dual-task motor training

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2021
    Last Updated
    March 25, 2021
    Sponsor
    Federal University of Paraíba
    Collaborators
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04819061
    Brief Title
    Predicting Outcomes From tDCS Intervention in Parkinson' Disease Using Electroencephalographic Biomarkers and Machine Learning Approach: the PREDICT Study Protocol
    Acronym
    PREDICT
    Official Title
    Predicting Outcomes From tDCS Intervention in Parkinson' Disease Using Electroencephalographic Biomarkers and Machine Learning Approach: the PREDICT Study Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba
    Collaborators
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Electroencephalogram, Transcranial Direct Current Stimulation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a sham-controlled, double-blind randomized multicentric clinical trial that will analyze patients with a confirmed diagnosis of Parkinson disease who were subjected to tDCS associated with dual-task motor training. Whe aim to predict response to tDCS treatment using electroencephalographic biomarkers and machine learning approach.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active group
    Arm Type
    Active Comparator
    Arm Description
    In the group G1 will be administered: tDCS active + dual-task motor training
    Arm Title
    Sham group
    Arm Type
    Sham Comparator
    Arm Description
    In the group G2 will be administered: tDCS sham + dual-task motor training
    Intervention Type
    Other
    Intervention Name(s)
    tDCS Active
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    tDCS sham
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Functional Mobility measured using the Timed Up and Go test (Podsiadlo D, Richardson S, 1991)
    Description
    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".
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suellen Andrade
    Phone
    986046032
    Ext
    5583
    Email
    suellenandrade@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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