NCT05987865

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
3mo left

Started Sep 2023

Typical duration for not_applicable parkinson-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

July 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

August 18, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

July 26, 2023

Last Update Submit

August 14, 2023

Conditions

Parkinson DiseaseHealthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • The effect of EEG-based neurofeedback on motor performance quantified as reaction time in patients with Parkinson's disease

    10 days

  • The effect of EEG-based neurofeedback on motor performance quantified as peak movement velocity in patients with Parkinson's disease

    10 days

  • The effect of EEG-based neurofeedback on parkinsonian tremor

    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

    10 days

  • The effect of EEG-based neurofeedback on motor performance quantified as reaction time in healthy age-matched control

    10 days

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Neurofeedback training

Interventions

Neurofeedback trainingBEHAVIORAL

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.

People with Parkinson's disease or Healthy Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Huiling Tan

CONTACT

01865 572483huiling.tan@ndcn.ox.ac.uk

Shenghong He

CONTACT

01865 572483shenghong.he@ndcn.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

August 18, 2023

Record last verified: 2023-07