None listed
Conditions
Brief summary
Chronic pain is a pervasive condition, affecting an estimated 20-40% of all people worldwide. There is now extensive evidence of structural and functional changes in the brain of people with chronic pain. Knowledge of functional changes in the pattern of brain activity in people with chronic pain has been used to develop EEG neurofeedback interventions, which non-invasively record brain signals with a wireless headset and then use game-based software applications to progressively train people with chronic pain to increase or decrease their brain (EEG) activity in the direction associated with pain-relief. This randomised controlled trial will compare the effects of 8 weeks of active (real) home-based EEG neurofeedback vs sham (fake) neurofeedback training in people with chronic pain. We hypothesize that, compared to the sham condition, active EEG neurofeedback training will lead to significantly larger improvements in pain intensity and a range of secondary outcomes including pain interference, psychological distress, sleep quality and quality of life.
Interventions
Treatment as usual plus 8 weeks of 4-5 x 40-minute sessions (32-40 sessions in total) of self-administered home-based active (real) 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 a
Treatment as usual plus 8 weeks of 4-5 x 40-minute sessions (32-40 sessions in total) of self-administered home-based active (real) 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.
Sponsors
Exsurgo Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
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