None listed
Conditions
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.
Interventions
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 U
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.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed