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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05987865
Other study ID # 249990
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 30, 2026

Study information

Verified date July 2023
Source University of Oxford
Contact Huiling Tan
Phone 01865 572483
Email huiling.tan@ndcn.ox.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 30, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Oxford King's College Hospital NHS Trust, St George's London University Hospitals NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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