Brain Train for Pain – V1.0
Research type
Research Study
Full title
Brain Train for Pain – A home-based neurofeedback intervention to treat the primary and secondary symptoms of chronic pain
IRAS ID
277936
Contact name
Nicholas C Birch
Contact email
Sponsor organisation
Exsurgo Rehab Limited
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
In order to address the growing problem of chronic pain management in the UK, a proof of concept/feasibility open label cohort pilot study has been devised to test a home-based self-administered non-pharmacological treatment utilising neurofeedback training with a headset and tablet-based software application. This study will replicate the protocol from a previous mixed methods clinical trial conducted at Glasgow University (NCT02678494) and address the limitations of this trial by: a) expanding the criteria to include individuals suffering from various types of chronic pain; b) measuring changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and quality of life; c) utilising a purpose-built software application run on a standard off the shelf tablet; and d) utilising a purpose-built headset that enables electrode placement at the correct location, is easy to use and structurally robust. Twenty participants will take part in pre-intervention assessments and 4 initial supervised sessions where they will be provided with detailed instructions on how to self-administer the training in the comfort of their own homes. They will then take part in 4-6 training sessions per week over an 8-week period (total sessions including training 36-52). Post-intervention assessments will then be conducted alongside a qualitative analysis of hardware/software usability, and the experience of doing neurofeedback training for chronic pain. Participant feedback on how the protocol, equipment and research could be improved will also be recorded to inform further research. Participants will also take part in online follow-up assessments at 1, 3, and 6 months after the intervention. Any adjustments to pain medication will also be recorded over this period. It is anticipated this study will provide initial evidence of the safety, efficacy, reliability and validity of a low-cost non-pharmacological solution to the physical, psychological and social difficulties experienced by individuals with chronic pain, with a view to a larger subsequent multisite trial.
REC name
North West - Preston Research Ethics Committee
REC reference
20/NW/0209
Date of REC Opinion
28 May 2020
REC opinion
Further Information Favourable Opinion