None listed
Conditions
Brief summary
Chronic pain is a pervasive condition, affecting an estimated 20-40% of all people worldwide. Preliminary findings suggest the electroencephalogram (EEG) neurofeedback training holds promise as a safe and effective intervention for the treatment of chronic pain, with improvements in pain, sleep, mood and quality of life reported. However, the long-term efficacy of EEG neurofeedback training remains unclear. Some studies show persistent benefits lasting several months after the initial training period ceases while others have observed a gradual reduction in efficacy, consistent with a detraining effect. This randomised controlled trial will explore whether the addition of booster sessions is able to better maintain the long term effects of an initial 8 weeks of EEG neurofeedback training. We hypothesize that, compared to no booster sessions, the use of booster neurofeedback sessions will enhance the long-term efficacy of active EEG neurofeedback for up to 12 months after an initial 8 week training period.
Interventions
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
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).
Sponsors
Exsurgo Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed