A Randomized, Double-Blind, Controlled Trial Protocol for Therapeutic Neuroscience Education in Chronic Migraine Patients: A Clinical–Neurophysiological Combined Study Design

Chronic migraine (CM) is a highly disabling condition, affecting about 2% of the global population. Non-pharmacological treatments can be optimal for their non-invasive nature. This prospective, randomized, double-blind, controlled trial aimed to test the efficacy of therapeutic neuroscience education (TNE) in CM. Early response biomarkers were also evaluated. A total of 80 CM patients were consecutively enrolled and randomly allocated to TNE or a general education program. Treatment effectiveness was evaluated at baseline (T1) and 2 months after the end of treatment (T4). We collected the responses to disability and comorbidity questionnaires at the start (T1) and end of treatment (T3, 10 weeks after start). Early response biomarkers were evaluated at screening (T0) and mid-way through the process (T2, 5 weeks after start). We expected that TNE would provide a greater benefit than the general education program, which served as the primary outcome of this study. We also expected that a change in clinical and neurophysiological measures could potentially occur, reflecting plasticity-induced reorganization and predicting clinical response. This is the first study selectively exploring the effect of TNE as a standalone treatment for CM. A new, effective treatment regime without interactions with other medication could be of great interest as an addition to migraine therapeutic strategies.