Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000846628p
Ethics application status
Submitted, not yet approved
Date submitted
13/07/2023
Date registered
8/08/2023
Date last updated
8/08/2023
Date data sharing statement initially provided
8/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
EEG Neurofeedback Intervention for Individuals with Neuropathic Pain following Spinal Cord Injury
Scientific title
Effectiveness of EEG Neurofeedback Intervention for Individuals with Neuropathic Pain following Spinal Cord Injury: A Randomised Clinical Trial
Secondary ID [1] 310126 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a randomised controlled trial, succeeding the single-case experimental design study registered as ACTRN12620000556943. The intervention in the current study has been improved to be self-administered by the participants at their homes.

Health condition
Health condition(s) or problem(s) studied:
Chronic neuropathic pain after spinal cord injury 330692 0
Condition category
Condition code
Injuries and Accidents 327515 327515 0 0
Other injuries and accidents
Neurological 327516 327516 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. We will be using an OpenBCI system with 3D printed headset. This EEG headset will be completed by a customised software and gaming interface developed in Unity game engine (Unity Technologies, USA).

Each participant in the treatment group will be provided with an EEG neurofeedback system to self-administer at home. The system includes: 1) an EEG headset which is 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.

The aim of this intervention is for participants in the treatment group 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 in the treatment group 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] 326526 0
Treatment: Devices
Comparator / control treatment
Participants in the control condition can continue with all the treatment options that they would normally have access to in the community.
Control group
Active

Outcomes
Primary outcome [1] 335380 0
The primary outcome is pain severity, assessed using the Brief Pain Inventory (BPI) - Pain Severity on four days over a week.
Timepoint [1] 335380 0
Immediately after completing their assigned protocol (Treatment or Control).
Secondary outcome [1] 424150 0
Brief Pain Inventory (BPI) - Pain Interference (modified for SCI)
Timepoint [1] 424150 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion
Secondary outcome [2] 424493 0
Neuropathic Pain Scale (NPS)
Timepoint [2] 424493 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion
Secondary outcome [3] 424494 0
Patient Health Questionnaire (PHQ-9), assessing depression
Timepoint [3] 424494 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion
Secondary outcome [4] 424495 0
Short-Form Survey (SF-36) – modified for SCI, assessing quality of life
Timepoint [4] 424495 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion
Secondary outcome [5] 424499 0
Pain Catastrophizing Scale (PCS)
Timepoint [5] 424499 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion
Secondary outcome [6] 424500 0
Healthcare Utilisation, determining the intake of prescribed and non-prescribed medications for the participants pain, and their visits to medical services and exercise physiologists, etc for their pain.
This is a self-report questionnaire, which is the only tool that we will be using for participants to report their medication intake and visits to healthcare services.
Timepoint [6] 424500 0
immediately post-intervention completion, 3-, 6- and 12-month post-intervention completion

Eligibility
Key inclusion criteria
• Having a complete or incomplete cervical, thoracic, or lumbar spinal cord injury,
• Being over 12 months post-injury,
• Having persistent neuropathic pain at or below the level of injury for more than three months,
• Having an average neuropathic pain intensity of at least 4/10 over the last week,
• Having an endorsement of more than 2 items on a 7-item Spinal Cord Injury Pain Instrument (SCIPI),
• Being 18 years of age or older,
• Being able to read and understand English, and
• Having the ability to fully participate in the EEG neurofeedback trial (must be able to put on the EEG headset or have a carer to assist).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not meeting the screening criteria.
• Having a cardiac pacemaker, cochlear implant, or deep brain stimulation,
• Having neurological disorders with cognitive impairment such as dementia, or a diagnosis of psychiatric disorders such as schizophrenia,
• Not being able to breathe independently, and
• Being located outside of Australia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician from the UNSW Stats Central who will not be involved in participant recruitment, treatment, or data collection will perform the block randomisation and will email the allocation schedule to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation. Participants will be randomised in 20 blocks of 6 and two blocks of 7.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All continuous outcomes (e.g., pain intensity, pain interference, etc.) and demographic measures (e.g., age, time since injury, etc.) will be summarised over time using measures of central tendency (sample mean, sample medians) and dispersion (sample variance, sample range) by group (Treatment vs Control). Categorical demographic variables will be summarised by proportions and compared between groups using Chi-square tests.

The mean between-group difference on the primary outcome and the secondary outcomes will be estimated with linear mixed models with time, treatment group, and the treatment x time interaction as fixed effects. For continuous outcomes, the estimated effects will be the differences in mean values between groups at immediately post-intervention, 3-, 6-, and 12-month follow-up assessments, and the overall difference across all time-points. To examine the longitudinal trends within individuals and between groups, linear mixed models and generalised estimating equations will be used. Specifically, piece-wise regression and test of interactions will focus on whether the treatment effects persist at 3-, 6-, and 12-month follow-up or whether the group mean converge over time.

The primary analysis will be conducted on an intention-to-treat basis. To account for potential missing data in secondary analyses, multiple imputation approaches will be employed. The linear mixed models and generalised estimating equations allow for missing data over time without case-wise deletion and account for variance inflation due to repeated observations. Because of the potential for type I error due to multiple comparisons, findings for analyses of secondary outcomes will be interpreted as exploratory. Both unadjusted and adjusted analyses will be conducted, and adjusted analyses will include age at baseline and gender.

All effects will be estimated with a 95% CI and all statistical tests will be 2-sided with a p-value of 0.05. All analyses will be conducted in R version 4.2.1 or SAS 9.4.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314285 0
Government body
Name [1] 314285 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 314285 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
Biological Sciences Building (E26), UNSW Gate 10, High St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 316229 0
None
Name [1] 316229 0
Address [1] 316229 0
Country [1] 316229 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313403 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 313403 0
Ethics committee country [1] 313403 0
Australia
Date submitted for ethics approval [1] 313403 0
31/07/2023
Approval date [1] 313403 0
Ethics approval number [1] 313403 0

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

Contacts
Principal investigator
Name 128030 0
Prof Sylvia Gustin
Address 128030 0
Neurorecovery Research Hub, Biological Sciences Building (E26), UNSW Gate 10, High St, Randwick NSW 2031
Country 128030 0
Australia
Phone 128030 0
+61413278336
Fax 128030 0
Email 128030 0
[email protected]
Contact person for public queries
Name 128031 0
Pauline Zahara
Address 128031 0
Neurorecovery Research Hub, Biological Sciences Building (E26), UNSW Gate 10, High St, Randwick NSW 2031
Country 128031 0
Australia
Phone 128031 0
+61404 039 419
Fax 128031 0
Email 128031 0
[email protected]
Contact person for scientific queries
Name 128032 0
Negin Hesam-Shariati
Address 128032 0
Neurorecovery Research Hub, Biological Sciences Building (E26), UNSW Gate 10, High St, Randwick NSW 2031
Country 128032 0
Australia
Phone 128032 0
+61490485051
Fax 128032 0
Email 128032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.