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Trial registered on ANZCTR
Registration number
ACTRN12625000161426p
Ethics application status
Submitted, not yet approved
Date submitted
20/01/2025
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Electroencephalographic (EEG) Neurofeedback Intervention for Individuals with Chronic Pain
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Scientific title
Evaluating the effect of an EEG neurofeedback intervention on pain intensity in individuals with chronic pain: A single case experimental design (SCED)
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Secondary ID [1]
299412
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
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Condition category
Condition code
Neurological
332871
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The investigational medical device that will be used as the intervention in this clinical trial is an EEG neurofeedback system based on a brain-computer interface (BCI) technology.
Each participant will be provided with an EEG neurofeedback system to self-administer at home. The system includes: 1) an in-house-developed EEG headset which has been designed for ease of use for the participants to be able to self-administer at home; 2) a Surface Pro containing a gaming interface developed using Unity game engine (Unity Technologies, USA).
The aim of this intervention is for participants to learn how to regulate their brain rhythms by playing an interactive game. The interactive gaming interface includes a neuromodulation protocol to suppress theta (4-7 Hz) and high beta (20-30 Hz) EEG rhythms, and to enhance sensorimotor rhythms (10-15 Hz). In this intervention, surface EEG is recorded from pain-related regions of the brain, e.g., C3 and C4 electrode sites. The targeted frequency bands are extracted and processed in real-time, then their calculated power is presented to the individual as a form of positive or negative visual feedback in a video game.
Participants will be instructed to find a mental strategy to regulate their brain rhythms via the game. Our gaming scenario provides neurofeedback in an interactive, goal-directed, virtual gaming environment. The visual feedback from the game will inform the participants whether they are doing well in terms of regulating their brain rhythms. For example, when the jellyfish character in the game is floating in the blue ocean, it means that all three EEG frequency band powers are regulated in the correct way, and the participants will earn points accordingly.
Participants will complete a session of EEG neurofeedback once a day for 20 days over a 4-week period. Each session will comprise 5x2.5-minute blocks of EEG neurofeedback with a break of up to 30 seconds between each block.
Participant compliance will be monitored by the data recorded during each session. Participant performance metrics are captured by the intervention system, associated with the participant’s unique identifier number. Researchers who are interacting with participants will have access to these data via an external web portal and external database. The web portal will include a dashboard involving all participants and the details on their progress.
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Intervention code [1]
330326
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Treatment: Devices
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Comparator / control treatment
There is no control group. In a single-case experimental design, each participant serve as their own control. The intervention phase will be compared with a no-treatment baseline phase.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Brief Pain Inventory (BPI) - pain severity.
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Assessment method [1]
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Timepoint [1]
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There is no primary timepoint in a SCED trial. Participants will complete the BPI-pain severity daily during all phases of the trial, including the baseline (7 to 17 days), intervention (20 days), immediate follow-up (7 days) and 5-week follow-up (7 days) phases.
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Secondary outcome [1]
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Brief Pain Inventory (BPI) - pain interference
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Assessment method [1]
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Timepoint [1]
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Participants will also complete the BPI-pain interference daily during all phases of the trial, including the baseline (7 to 17 days), intervention (20 days), immediate follow-up (7 days) and 5-week follow-up (7 days) phases.
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Eligibility
Key inclusion criteria
Inclusion criteria:
1) aged between 18-80 years
2) experiencing persistent or recurrent pain for a duration of at least three months
3) average pain severity of 4/10 over the last seven days (at the time of screening)
4) able to read and understand English
5) willing to complete 20 sessions of intervention over four weeks
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1) have been diagnosed with any severe neurodegenerative and/or psychiatric disorders
2) have a cardiac pacemaker, cochlear implant, or deep brain stimulation
3) undergoing any changes to their current treatment regimen
4) not residing in Australia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
304067
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/01/2025
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Approval date [1]
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Ethics approval number [1]
304420
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Summary
Brief summary
A single-case experimental design (SCED) with multiple baselines across participants will be conducted to evaluate the effect of a home-based self-directed EEG neurofeedback intervention for individuals with chronic pain. In this study, the primary and secondary outcome measures will be assessed daily across four phases: baseline, intervention, immediate follow-up, and 5-week follow-up. The daily assessments before, during, and after the intervention provide an objective basis for evaluating the treatment effect at an individual level, where participants serve as their own control. In a multiple-baseline design across participants, the intervention phase is initiated in a staggered sequence, resulting in varying duration of the baseline phase between participants. The multiple-baseline design estimates the effect of an intervention by demonstrating that any observed changes in the outcome measures are systematically aligned with the initiation of the intervention. In this study, we hypothesise that the EEG neurofeedback intervention has an effect on reducing pain severity and pain interference across participants when comparing the baseline phase to the intervention and the 5-week follow-up phases.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sylvia Gustin
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Address
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NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
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Country
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Australia
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Phone
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+61 2 9348 1004
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sylvia Gustin
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Address
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NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
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Country
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Australia
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Phone
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+61 2 9348 1004
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Negin Hesam-Shariati
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Address
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NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
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Country
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Australia
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Phone
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+61 2 90652169
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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Researchers who contact us via email and provide a registration for their study.
Conditions for requesting access:
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-
What individual participant data might be shared?
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De-identified participant data.
What types of analyses could be done with individual participant data?
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All types of secondary analysis including meta-analyses.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be available at the end of the trial once the study is published, starting from 20 December 2030; available for 7 years after publication.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
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Data can be obtained by contacting the corresponding author:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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