Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 3, 2020
Date Accepted: Sep 1, 2020
Evaluation of the effectiveness of a novel brain-computer interface neuromodulative intervention to relieve neuropathic pain following spinal cord injury: protocol for a single-case experimental design with multiple baselines
ABSTRACT
Background:
Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury (SCI). SCI neuropathic pain often remains poorly responsive to existing pharmacological and non-pharmacological treatments. A growing body of evidence supports the potential for brain-computer interface (BCI) systems to reduce SCI neuropathic pain via electroencephalography (EEG) neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention.
Objective:
The primary objective of this study is to evaluate the effectiveness of a multi-day course of BCI-N intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following SCI.
Methods:
We have developed a novel BCI-based neuromodulative (BCI-N) intervention for SCI neuropathic pain. Our BCI-N treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. A single-case experimental design (SCED) with multiple baselines will be used to examine the effectiveness of our self-developed BCI-N intervention for the treatment of SCI neuropathic pain. Three participants with SCI neuropathic pain will be recruited. Each participant will be randomly allocated to a different baseline phase (i.e., 7, 10 or 14 days), which will then be followed by 20 sessions of 30-min BCI-N intervention over a 4-week period. The visual analogue scale assessing average pain intensity will serve as the primary outcome measure. Pain interference will also be assessed as a secondary outcome domain. Generalisation measures will assess quality of life, sleep quality, anxiety and depressive symptoms as well as resting-state EEG and thalamic γ-aminobutyric acid concentration (GABA).
Results:
This study was approved by the Human Research Committees of the University of New South Wales (HC190411) in July 2019 and the University of Technology Sydney (ETH19-4090) in January 2020. The trial has been planned to commence in October 2020, and the results are expected to be published by the end of 2021.
Conclusions:
This clinical trial using SCED methodology has been designed to evaluate the effectiveness of a novel BCI-N treatment for people with neuropathic pain after SCI. SCEDs are considered a viable alternative approach to randomised clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379619&isReview=true
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