Parkinson DiseaseNCT05987865
Neurofeedback Training for PD
A study testing Neurofeedback training in people with Parkinson Disease and Healthy, run by University of Oxford.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy
- What is being tested?
- Neurofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Parkinson Disease, Healthy
- Being tested
- Neurofeedback training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinson's disease or Healthy Control | Experimental | The experimental arm involves either patients with PD or healthy control, who will receive both experimental or non-experimental (control) intervention conditions. Receives: Behavioral: Neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987865
- Sponsor's protocol ID
- 249990
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG- or STN LFP-based Neurofeedback Training for Improving Motor Functions in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05987865
- Acronym / sponsor ID
- 249990
- Conditions
- Parkinson Disease, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, King's College Hospital NHS Trust
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's disease or Healthy Control | Experimental | Behavioral: Neurofeedback trainingThe experimental arm involves either patients with PD or healthy control, who will receive both experimental or non-experimental (control) intervention conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback trainingFeatures 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. | Behavioural | People with Parkinson's disease or Healthy Control |
Primary outcome
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.
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.
6 secondary outcomes
The effect of EEG-based neurofeedback on motor performance quantified as reaction time in patients with Parkinson's disease
Time frame: 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 effect of EEG-based neurofeedback on parkinsonian tremor
Time frame: 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
The effect of EEG-based neurofeedback on motor performance quantified as reaction time in healthy age-matched control
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Parkinson Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Not yet recruitingPhase 2
Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
Parkinson Disease
RecruitingPhase 3
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Parkinson Disease and Healthy, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiling Tan (01865 572483 ext. 44, huiling.tan@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.