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
About this trial
This is an interventional basic science trial for Parkinson Disease
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)
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
NCT ID
NCT05987865
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
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.
Learn more about this trial
Neurofeedback Training for PD
We'll reach out to this number within 24 hrs