Neurofeedback Training for PD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Parkinson Disease
• Intervention / Treatment: Behavioral: Neurofeedback training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiling Tan; Phone Number: 44 01865 572483; Email: huiling.tan@ndcn.ox.ac.uk
• Study Contact Backup: Name: Shenghong He; Phone Number: 44 01865 572483; Email: shenghong.he@ndcn.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: People with Parkinson's disease or Healthy Control; 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; 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.

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: King's College Hospital NHS Trust; St George's London University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 249990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No