Neurofeedback Training for PD

Study Overview
=================
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.

Official Title
-----------------
EEG- or STN LFP-based Neurofeedback Training for Improving Motor Functions in Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Healthy

Intervention / Treatment
-----------------
* Behavioral: Neurofeedback training


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People with Parkinson's disease or Healthy Control<br>The experimental arm involves either patients with PD or healthy control, who will receive both experimental or non-experimental (control) intervention conditions. | Behavioral: Neurofeedback training<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days | 
| 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. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days | 
| 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. | 10 days |