JMIR Publications

ABSTRACT

Background:

Painful diabetic peripheral neuropathy (P-DPN) is a common and disabling complication of diabetes affecting a substantial proportion of patients and significantly impairing quality of life. Current pharmacological treatments provide only modest pain relief and are often associated with side effects that limit long-term adherence. Consequently, there is a critical need for novel, mechanism-based treatment approaches that target the underlying neurobiological processes of chronic pain.

Objective:

The aim of this study is to investigate the efficacy and underlying neurophysiological mechanisms of source-localized EEG neurofeedback (EEG-NF) in individuals with P-DPN compared with a sham neurofeedback control condition.

Methods:

The study is a randomized, multi-center, blinded, and sham-controlled clinical trial investigating the treatment efficacy of source localised EEG-NF in individuals with P-DPN. Fifty-five subjects with either type 1 or type 2 diabetes, diabetic neuropathy (DPN) and an average pain ≥4 on a Numeric Rating Scale (NRS) of 0–10 will be randomized 1:1 to receive either active EEG-NF or sham NF across 10 sessions. The primary outcome is the change in mean 7-day average pain intensity (NRS) from baseline (T0) to post-intervention (T1) measured by an electronic pain diary. Secondary outcomes include changes in different aspects of neuropathic pain (Neuropathic Pain Scale (NPS), Pain Catastrophizing Scale (PCS), sleep interference (PROMIS SF Sleep and Fatigue), mental health (PROMIS SF depression), and health-related quality of life (WHOQL-Brief). Neurophysiological outcomes will also be assessed using quantitative EEG and standardized low-resolution electromagnetic tomography (swLORETA) using predefined metrics of abnormal cortical activity, connectivity as well as the achieved degree of EEG normalisation. This trial will evaluate both the efficacy and potential mechanisms of EEG-NF in the treatment of P-DPN.

Results:

Ethical approval for the study was obtained by the Regional Committees on Health Research Ethics in Region of Southern Denmark (Projekt-ID S-20220074). Ethical approval date 17 May 2024, first patient first visit 14 August 2024. The data collection is expected to be done in December 2026. The trial is registered at ClinicalTrials.gov (NCT06603792).

Conclusions:

This trial will provide important evidence regarding the efficacy and neurophysiological mechanisms of EEG-NF as a non-pharmacological treatment for P-DPN. If effective, EEG-NF may represent a novel mechanism-based intervention targeting central pain processing abnormalities in P-DPN and contribute to the development of more personalized treatment approaches for chronic neuropathic pain. Clinical Trial: ClinicalTrials.gov (NCT06603792)