Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001056886
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
10/08/2021
Date last updated
16/11/2021
Date data sharing statement initially provided
10/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can booster sessions prolong the long-term impacts of 8 weeks of home-based electroencephalography neurofeedback for the treatment of chronic pain?
Scientific title
The effects of booster sessions on long term impact on pain management of 8 weeks of home-based electroencephalography neurofeedback for the treatment of chronic pain: A randomised controlled trial.
Secondary ID [1] 304706 0
None
Universal Trial Number (UTN)
U1111-1267-6649
Trial acronym
Linked study record
This record is a follow up study related to ACTRN12621000667819

Health condition
Health condition(s) or problem(s) studied:
chronic pain
 322721 0
Condition category
Condition code
Anaesthesiology 320310 320310 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The initial intervention (induction phase) will be 8 weeks of 4-5 x 40-minute sessions (32-40 sessions in total) of self-administered home-based electroencephalogram (EEG) neurofeedback training using a custom-built EEG headset and a tablet-based app with games designed to train participants to upregulate power in the alpha frequency band of the C4 electrode, with the opportunity to simultaneously downregulate beta and theta frequency band power. For example, participants will aim to keep a hot air balloon afloat by upregulating their alpha band power and receive additional auditory feedback when alpha band power is maintained above the training threshold for more than 5 seconds. Individual training thresholds will be set based on baseline EEG recordings at the start of each session. Adherence (number of sessions completed) will be automatically captured on the app.

After the induction phase, those randomised to the intervention group will receive a tapered series of booster EEG neurofeedback sessions over the subsequent 12 month follow up period (maintenance phase). The training protocol for the booster sessions will be identical to those described in the induction phase. Immediately after the 8-week induction phase, participants will complete booster sessions according to the following schedule Week 1: 3 x 40 minute sessions, Weeks 2-3: 2 x 40 minute sessions, Week 4: 1 x 40 minute session; Weeks 5-12: 4 x fortnightly 40 minute sessions, Weeks 13-52: 9 x monthly 40 minute sessions (21 booster sessions in total).
Intervention code [1] 321086 0
Treatment: Devices
Comparator / control treatment
The initial intervention (induction phase) will be 8 weeks of 4-5 x 40-minute sessions (32-40 sessions in total) of self-administered home-based electroencephalogram (EEG) neurofeedback training using a custom-built EEG headset and a tablet-based app with games designed to train participants to upregulate power in the alpha frequency band of the C4 electrode, with the opportunity to simultaneously downregulate beta and theta frequency band power. For example, participants will aim to keep a hot air balloon afloat by upregulating their alpha band power and receive additional auditory feedback when alpha band power is maintained above the training threshold for more than 5 seconds. Individual training thresholds will be set based on baseline EEG recordings at the start of each session. Adherence (number of sessions completed) will be automatically captured on the app.

After the initial 8 week induction phase, those randomised to the control group will be asked to return their headset and tablet and will not receive any further EEG neurofeedback during the 12 month follow-up period (maintenance phase).
Control group
Active

Outcomes
Primary outcome [1] 328160 0
Change in Brief Pain Inventory Average Pain Rating
Timepoint [1] 328160 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [1] 397885 0
Change in Brief Pain Inventory Worst Pain Rating
Timepoint [1] 397885 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [2] 397886 0
Change in Depression, Anxiety and Stress (DASS-21) score
Timepoint [2] 397886 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [3] 397887 0
Change in the Pain Catastrophising Scale
Timepoint [3] 397887 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [4] 397888 0
Change in Pittsburgh Sleep Quality Index
Timepoint [4] 397888 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [5] 397889 0
Change in Euro-QOL5D quality of life score
Timepoint [5] 397889 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [6] 397890 0
Change in the Central Sensitization Inventory Score
Timepoint [6] 397890 0
From Baseline of the induction phase to the Beginning of week 53 of the maintenance phase.
Secondary outcome [7] 397891 0
Patient global impression of improvement with respect to their chronic pain condition
Timepoint [7] 397891 0
Beginning of week 53 of the maintenance phase
Secondary outcome [8] 397892 0
Number of treatment responders as assessed by change in brief pain inventory average pain score
Timepoint [8] 397892 0
Calculated from measurements at baseline and the beginning of week 53 of the maintenance phase.

Eligibility
Key inclusion criteria
Males and females 18 years of age or older who have had ongoing pain for 3 months or more; have an average pain rating in the last week of at least 4/10 at the time of initial screening and a head circumference of 520-620mm will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be as follows: Previous neurofeedback training; Contraindication for neurofeedback training including: serious head injury, history of seizures, cognitive impairment, neurological disorder or major psychiatric disorder; Dreadlocks, braids, beads or any other hairstyle or head covering that cannot be removed and is incompatible with EEG neurofeedback training; Any physical impairment that prevents home-based EEG neurofeedback training; Implanted electronic neuromodulation device, pacemaker or loop recorder; Any change in medication or treatment planned in the 4 weeks prior to or during the initial intervention period; Not fluent in English.

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)
The study personnel conducting the recruitment and screening procedures will be unaware of the allocation schedule, which will be password protected and kept "off site" with a central study administrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio using a computer generated randomisation schedule with permuted blocks of random size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a minimal clinically important difference of 1.5 points in the change in BPI average pain between groups (assuming a standard deviation of 2.5) with power of 80% and a two-sided alpha level of 0.05, 92 participants are required. To account for a dropout rate of up to 20%, 116 participants will be recruited..

Linear or generalised linear mixed effects models will be used to assess the treatment effects of the booster session condition vs the control condition on the primary outcome measure (BPI average pain).Two levels of analysis will be performed 1) intention-to-treat and 2) according to treatment received. Secondary outcomes will be also analysed and compared between groups using linear or generalised linear mixed effects models. Analysis of differential versus non-differential occurrence of missing observations will be carried out to assure that any missing data are not systematic and further, to account for potential bias in the intention-to-treat analyses. We will report our imputation methods, and we will perform a sensitivity analysis, examining effects on the outcomes reported, with explicit reporting of missing observations and withdrawals

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2021
Actual
14/09/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
116
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 23943 0
New Zealand
State/province [1] 23943 0
Auckland

Funding & Sponsors
Funding source category [1] 309076 0
Commercial sector/Industry
Name [1] 309076 0
Exsurgo Ltd
Country [1] 309076 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Exsurgo Ltd.
Address
Unit i, 45 William Pickering Drive, Albany, Auckland, 0632, New Zealand
Country
New Zealand
Secondary sponsor category [1] 310022 0
None
Name [1] 310022 0
Address [1] 310022 0
Country [1] 310022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308950 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308950 0
Ethics committee country [1] 308950 0
New Zealand
Date submitted for ethics approval [1] 308950 0
26/03/2021
Approval date [1] 308950 0
17/05/2021
Ethics approval number [1] 308950 0
21/CEN/98

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

Contacts
Principal investigator
Name 112442 0
Dr David Rice
Address 112442 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland, 0620

Waitemata Pain Services, Level 10, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0622
Country 112442 0
New Zealand
Phone 112442 0
+64 9 921 7032
Fax 112442 0
Email 112442 0
[email protected]
Contact person for public queries
Name 112443 0
David Rice
Address 112443 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland, 0620

Waitemata Pain Services, Level 10, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0622
Country 112443 0
New Zealand
Phone 112443 0
+64 9 921 7032
Fax 112443 0
Email 112443 0
[email protected]
Contact person for scientific queries
Name 112444 0
David Rice
Address 112444 0
School of Clinical Sciences, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland, 0620

Waitemata Pain Services, Level 10, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0622
Country 112444 0
New Zealand
Phone 112444 0
+64 9 921 7032
Fax 112444 0
Email 112444 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
Participant consent has not been given. Some of the data may be commercially sensitive.


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.