This study evaluates the effectiveness of neurofeedback (teaching participants to gain control over their own brainwaves) in chronic pain. The study is made up of four pilot studies. Participants who take part will undergo the cold pressor test, submerging their hand in cold water in order to simulate chronic pain. Brain activity will be measured using electroencephalography (EEG).

Chronic pain is a persisting pain which often exists in the absence of detectable tissue damage. It is also associated with feelings of depression, anxiety, and despair. Current treatments for chronic pain usually involves drug treatments, which often has unwanted side effects.

This study aims to assess the effectiveness of neurofeedback, which refers to teaching participants to gain control over their own brainwaves, as an intervention to treat chronic pain. It is believed that by teaching participants to gain control over a brain signal associated with pain resilience, the participant can reduce some of the negative effects associated with chronic pain.

Participants who take part in this study will have their brain activity recorded using electroencephalography (EEG), and have pain elicited using the cold pressor test (CPT), which involves the participant submerging their wrist in cold water to elicit a chronic pain-like sensation. This is a safe, regularly used method, and the participant is free to remove their hand early if the pain becomes too great.

Some participants who take part will undergo neurofeedback training, which will involve them viewing a signal associated with pain resilience, and learning to increase it over multiple sessions.

Inclusion Criteria:

• Willing and able to give informed consent for participation in the study
• Must be aged 40 or older

Exclusion Criteria:

• Current or planned hospitalisation during the period of study.
• Non-English speaking participants
• Participants already involved in clinical trials, if it is not possible to schedule around this
• Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study.
• Patients with chronic pain in both upper limbs
• History of brain injury, stroke or neurosurgical procedures
• An implanted neurostimulator (e.g., deep brain stimulator)
• Damaged skin tissue on the head, or a skin condition such as severe eczema, or any skin allergies
• Failure of cognitive test (Montreal Cognitive Assessment) will exclude participants from taking part in studies that use neurofeedback procedures
• Some but not all of the study will be unavailable to participants currently undergoing psychotherapy (such as cognitive behavioural therapy).

No individually identifiable participant data will be shared outside of the research group, and the University of Manchester (for the purposes of audit).

Non-identifiable (pseudo-anonymised) data will be shared with TIYGA Health through their phone app if participants choose to upload this information, however, no phone location data, names, ore any other personal information will be shared with them. Participants are free to choose not to use the phone app with no penalties for not taking part

Non-identifiable information will be shared, only when participants choose to share it during the neurofeedback training sessions (8-16 weeks). TIYGA Health will retain the data in line with GDPR (General Data Protection Regulation) requirements for pseudo-anonymised data - retaining data for 5 years before deletion (after last data entry), and may archive accounts if no new data is added for 2 years

Please contact us at james.henshaw-2@manchester.ac.uk and we will provide email access to the full DMP (Data Management Plan, available at link below)

A number of the studies include double-blind neurofeedback, where half of the participants receive sham neurofeedback, and half receive actual neurofeedback from a region thought to increase pain resilience. The experimenter, participant, and care provider will all be blinded as to which condition the participant is in until the participant leaves the study.