Efficacy of tDCS and EEG Neurofeedback, individually and combined, on Neuropathic Pain following spinal cord injury: Protocol for a Randomised Controlled Trial

Study Design: Randomised controlled trial (RCT) Protocol Objectives: Neuropathic pain (NP) affects approximately 60% of individuals with spinal cord injury (SCI). Existing pharmacological treatments provide modest relief and are often limited by adverse effects, while non-pharmacological options show small effects at best. Thus, there remains a need for accessible, mechanism-informed treatments for SCI-NP. This protocol describes an RCT evaluating the efficacy of two promising home-based neuromodulatory interventions for SCI-NP - electroencephalography neurofeedback (EEG-NF) and transcranial direct current stimulation (tDCS) - tested both independently and in combination. Setting: Australia-wide Methods: A partially double-blinded (i.e. 1 treatment blinded, the other not), 2×2 factorial RCT will be implemented. Adults with SCI-NP (N=192) will be randomised to one of four groups: EEG-NF + active tDCS, EEG-NF + sham tDCS, active tDCS, or sham tDCS. Participants will complete 20 home-based sessions over 5 weeks. The primary outcome is pain severity at 6 weeks post-randomisation. Secondary outcomes include pain severity at 16, 26 and 52 weeks, and worst pain intensity, pain interference, sleep disturbance, depressive symptoms, and health-related quality of life at 6, 16, 26 and 52 weeks post-randomisation. Results: The trial has been prospectively registered and approved by the University of New South Wales Human Research Ethics Committee. Conclusion: This trial will provide the first large-scale evaluation of home-based EEG-NF and tDCS, delivered individually and in combination, for SCI-NP. If effective, these scalable interventions may support integration of home-based neuromodulation into routine care for this population. Funding: Medical Research Future Fund (MRFF) Clinical Trials Activity