Clinical trial NCT05987865: Neurofeedback Training for PD
Official title: EEG- or STN LFP-based Neurofeedback Training for Improving Motor Functions in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Healthy
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: St George's London University Hospitals NHS Foundation Trust
name: King's College Hospital NHS Trust
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: The feasibility of using EEG-based neurofeedback to help patients with Parkinson's disease to volitionally modulate pathological brain activities measured non-invasively.
timeFrame: 10 days
measure: Learning effect of the neurofeedback training with multiple training sessions
timeFrame: 10 days
Secondary outcomes:
measure: The effect of EEG-based neurofeedback on motor performance quantified as reaction time in patients with Parkinson's disease
timeFrame: 10 days
measure: The effect of EEG-based neurofeedback on motor performance quantified as peak movement velocity in patients with Parkinson's disease
timeFrame: 10 days
measure: The effect of EEG-based neurofeedback on parkinsonian tremor
timeFrame: 10 days
measure: The effect of EEG-based neurofeedback on motor Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
timeFrame: 10 days
measure: The effect of EEG-based neurofeedback on motor performance quantified as reaction time in healthy age-matched control
timeFrame: 10 days
measure: 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.
timeFrame: 10 days
Other outcomes:
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