Neurofeedback Training for PD

August 14, 2023 updated by: University of Oxford

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional 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
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.
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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.
Time Frame: 10 days
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

King's College Hospital NHS Trust
St George's London University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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