A home-based self-directed EEG neurofeedback intervention for people with chronic neuropathic pain following spinal cord injury (the StoPain Trial): description of the intervention

Abstract

Study design: Randomised controlled trial.

Objectives: The objective is to describe an electroencephalography (EEG) neurofeedback intervention that will be provided in a randomised controlled trial for people with neuropathic pain following spinal cord injury (SCI): the StoPain Trial. In this trial, participants in the treatment group will implement an EEG neurofeedback system as an analgesic intervention at home, while participants in the control group will continue with the treatments available to them in the community.

Setting: University-based study in Sydney, Australia.

Methods/results: This manuscript describes the rationale and components of the EEG neurofeedback intervention designed for individuals with SCI neuropathic pain and intended for home-based implementation. Our report is based on the criteria of the Template for Intervention Description and Replication (TIDieR) checklist, and includes why the efficacy of EEG neurofeedback will be investigated, what will be provided, who will administer it, and how, where, when, and how much the EEG neurofeedback intervention will be administered.

Conclusions: This manuscript provides a detailed description of a complex intervention used in a randomised controlled trial. This description will facilitate the subsequent interpretation of the trial results and allow for the replication of the intervention in clinical practice and future trials.

Sponsorship: Australian Government Medical Research Future Fund (2020 Rare Cancers Rare Diseases and Unmet Needs Scheme: 2006020).

Fig. 1. The in-house-developed EEG headset.

A The headset is equipped with an OpenBCI biosensing board, with two sensors at C3 and C4 electrode sites, and ear-clips serving as the reference electrodes. B The placement of the EEG headset on the head.

Fig. 2. Impedance verification instructions.

A Prticipants will be instructed to check the electrodes impedance connection. If participants encounter issues to turn the impedance indicators green (< 50 kΩ), they will be guided to press the troubleshooting button, prompting access to the troubleshooting screen. B In the troubleshooting screen, they will be led through some simple steps to resolve the issue.

Fig. 3. Resting-state EEG instructions.

A Participants will be directed to look at a fixation cross for a duration of two minutes to record their resting-state EEG. This recording is used to set a threshold for the targeted frequencies during the games. B The fixation cross.

Fig. 4. Sample game images.

A The Plane game: During the Plane game, the plane will fly in the blue sky when participants regulate the targeted frequency bands. B The Rocket game: During the Rocket game, the rocket will accelerate through the dark space when participants regulate the targeted frequency bands.

Fig. 5. Game instructions.

To play the games, participants will be encouraged to use mental strategies that promote a relaxed and mindful state, ones that align all targeted frequency bands in the correct direction.