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Neurofeedback Training for PD

Primary Purpose

Parkinson Disease, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback training
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants with symptomatic Parkinson's disease or age-matched healthy control Adequate understanding of verbal explanation or written information given in English Able and willing to give informed consent. Normal or corrected-to-normal vision Exclusion Criteria: Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    People with Parkinson's disease or Healthy Control

    Arm Description

    The experimental arm involves either patients with PD or healthy control, who will receive both experimental or non-experimental (control) intervention conditions.

    Outcomes

    Primary Outcome Measures

    The feasibility of using EEG-based neurofeedback to help patients with Parkinson's disease to volitionally modulate pathological brain activities measured non-invasively.
    The final position of the cursor and beta power changes after neurofeedback training will be measured and reported.
    Learning effect of the neurofeedback training with multiple training sessions
    The final positions of the cursor and the changes in beta power will be measured and compared across different training sessions.

    Secondary Outcome Measures

    The effect of EEG-based neurofeedback on motor performance quantified as reaction time in patients with Parkinson's disease
    The reaction time following cued motor task will be measured, and compared between training and no-training conditions.
    The effect of EEG-based neurofeedback on motor performance quantified as peak movement velocity in patients with Parkinson's disease
    The peak movement velocity during the cued motor task will be measured, and compared between training and no-training conditions.
    The effect of EEG-based neurofeedback on parkinsonian tremor
    The acceleration data will be measured from patient's arms during neurofeedback training, which will be used to quantity the tremor severity by looking at the power at patient specific tremor frequency band. The comparison on tremor severity between training and no-training conditions will be reported.
    The effect of EEG-based neurofeedback on motor Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
    MDS-UPDRS is a comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's. Each question will be scored between 0 and 5, with a higher value indicates more severe assessment. In this study, the motor part of UPDRS scores on the patients will be measured, and compared before and after neurofeedback training.
    The effect of EEG-based neurofeedback on motor performance quantified as reaction time in healthy age-matched control
    The reaction time following cued motor task will be measured, and compared between training and no-training conditions in healthy age-matched control group.
    The peak movement velocity during the cued motor task will be measured, and compared between training and no-training conditions in healthy age-matched control group.
    This will be assessed by comparing the peak movement velocity during the cued motor task between training and no-training conditions.

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    August 14, 2023
    Sponsor
    University of Oxford
    Collaborators
    St George's London University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05987865
    Brief Title
    Neurofeedback Training for PD
    Official Title
    EEG- or STN LFP-based Neurofeedback Training for Improving Motor Functions in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    August 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oxford
    Collaborators
    St George's London University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust

    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
    The goal of this clinical trial is to test neurofeedback training in both people with Parkinson's disease and healthy control. The main questions it aims to answer are: To demonstrate that EEG based or STN LFP based neurofeedback can help patients with Parkinson's disease to volitionally modulate pathological brain activities measured non-invasively; To evaluate the learning effect of the neurofeedback training with multiple training sessions Patient participants will be asked to receive the research intervention called neurofeedback training for maximal three separate sessions. During the intervention, the participants will also be asked to press a pinch meter as fast as possible in order to measure the reaction time, meanwhile, different type of brain signals will be recorded. . This will be a within-subject cross-over study contrasting the effect of the neurofeedback training and no training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Healthy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    People with Parkinson's disease or Healthy Control
    Arm Type
    Experimental
    Arm Description
    The experimental arm involves either patients with PD or healthy control, who will receive both experimental or non-experimental (control) intervention conditions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Neurofeedback training
    Intervention Description
    Features related to PD symptoms will be extracted from the brain recordings in real-time and used to drive a visual cursor on a computer screen placed in front of the participant, while the participant will be asked to try to control the cursor by regulating their brain signals.
    Primary Outcome Measure Information:
    Title
    The feasibility of using EEG-based neurofeedback to help patients with Parkinson's disease to volitionally modulate pathological brain activities measured non-invasively.
    Description
    The final position of the cursor and beta power changes after neurofeedback training will be measured and reported.
    Time Frame
    10 days
    Title
    Learning effect of the neurofeedback training with multiple training sessions
    Description
    The final positions of the cursor and the changes in beta power will be measured and compared across different training sessions.
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    The effect of EEG-based neurofeedback on motor performance quantified as reaction time in patients with Parkinson's disease
    Description
    The reaction time following cued motor task will be measured, and compared between training and no-training conditions.
    Time Frame
    10 days
    Title
    The effect of EEG-based neurofeedback on motor performance quantified as peak movement velocity in patients with Parkinson's disease
    Description
    The peak movement velocity during the cued motor task will be measured, and compared between training and no-training conditions.
    Time Frame
    10 days
    Title
    The effect of EEG-based neurofeedback on parkinsonian tremor
    Description
    The acceleration data will be measured from patient's arms during neurofeedback training, which will be used to quantity the tremor severity by looking at the power at patient specific tremor frequency band. The comparison on tremor severity between training and no-training conditions will be reported.
    Time Frame
    10 days
    Title
    The effect of EEG-based neurofeedback on motor Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
    Description
    MDS-UPDRS is a comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's. Each question will be scored between 0 and 5, with a higher value indicates more severe assessment. In this study, the motor part of UPDRS scores on the patients will be measured, and compared before and after neurofeedback training.
    Time Frame
    10 days
    Title
    The effect of EEG-based neurofeedback on motor performance quantified as reaction time in healthy age-matched control
    Description
    The reaction time following cued motor task will be measured, and compared between training and no-training conditions in healthy age-matched control group.
    Time Frame
    10 days
    Title
    The peak movement velocity during the cued motor task will be measured, and compared between training and no-training conditions in healthy age-matched control group.
    Description
    This will be assessed by comparing the peak movement velocity during the cued motor task between training and no-training conditions.
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants with symptomatic Parkinson's disease or age-matched healthy control Adequate understanding of verbal explanation or written information given in English Able and willing to give informed consent. Normal or corrected-to-normal vision Exclusion Criteria: Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huiling Tan
    Phone
    01865 572483
    Ext
    44
    Email
    huiling.tan@ndcn.ox.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shenghong He
    Phone
    01865 572483
    Ext
    44
    Email
    shenghong.he@ndcn.ox.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The investigators will share the fully anonymized brain recordings and behavioural data on the Oxford Research Archives or the MRC Brain Network Dynamics Unit Data Sharing platform.

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    Neurofeedback Training for PD

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