None listed
Conditions
Brief summary
This is a randomised controlled, parallel design, single-blinded trial to examine the efficacy of a novel EEG neurofeedback intervention in comparison with the control condition for individuals with neuropathic pain after SCI. Participants will be randomised to receive EEG neurofeedback (Treatment condition) or ‘treatment as usual’ (Control condition). Participants in the treatment condition 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. Participants in the control condition can continue with all the treatment options that they would normally have access to in the community. We hypothesise that 1) EEG neurofeedback intervention will show greater reduction in self-reported pain intensity for people with neuropathic pain after SCI following the intervention compared to the control condition. 2) Completion of the EEG neurofeedback intervention may be associated with pre- to post-intervention improvement in psychosocial factors.
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. 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 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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed