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NCT Number: NCT05987865

Neurofeedback Training for PD

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurofeedback training

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huiling Tan

CONTACT

[email protected]

01865 572483 ext. 44

Shenghong He

CONTACT

[email protected]

01865 572483 ext. 44

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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