Trial Review

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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
Scientific title
Evaluating the effect of an EEG neurofeedback intervention on pain intensity in individuals with chronic pain: A single case experimental design (SCED)
Secondary ID [1] 299412 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 336332 0
Condition category
Condition code
Neurological 332871 332871 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330326 0
Treatment: Devices
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340395 0
Brief Pain Inventory (BPI) - pain severity.
Timepoint [1] 340395 0
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.
Secondary outcome [1] 443945 0
Brief Pain Inventory (BPI) - pain interference
Timepoint [1] 443945 0
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.

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303918 0
Government body
Name [1] 303918 0
National Health and Medical Research Council (NHMRC)
Country [1] 303918 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 304067 0
None
Name [1] 304067 0
Address [1] 304067 0
Country [1] 304067 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304420 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 304420 0
Ethics committee country [1] 304420 0
Australia
Date submitted for ethics approval [1] 304420 0
20/01/2025
Approval date [1] 304420 0
Ethics approval number [1] 304420 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96894 0
Prof Sylvia Gustin
Address 96894 0
NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
Country 96894 0
Australia
Phone 96894 0
+61 2 9348 1004
Fax 96894 0
Email 96894 0
[email protected]
Contact person for public queries
Name 96895 0
Sylvia Gustin
Address 96895 0
NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
Country 96895 0
Australia
Phone 96895 0
+61 2 9348 1004
Fax 96895 0
Email 96895 0
[email protected]
Contact person for scientific queries
Name 96896 0
Negin Hesam-Shariati
Address 96896 0
NeuroRecovery Research Hub, level 1, Biological Sciences Building, Gate 10, UNSW, Kensington, NSW 2052
Country 96896 0
Australia
Phone 96896 0
+61 2 90652169
Fax 96896 0
Email 96896 0
[email protected]

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:
• Researchers who contact us via email and provide a registration for their study.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified participant data.

What types of analyses could be done with individual participant data?
• 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:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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.