Effect of neurofeedback-assisted mindfulness training on migraine severity, associated disability, sleep quality, and emotional distress: protocol for a randomized controlled trial

Background Migraine is a highly prevalent neurological disorder and a leading cause of worldwide disability, exerting significant clinical, social, and economic burdens. While pharmacological options exist, their efficacy is often limited by tolerability issues and risk of medication-overuse headache. Neurofeedback (NF) combined with mindfulness training has emerged as a promising non-pharmacological neuromodulation technique. However, clinical evidence in migraine management remains limited by methodological heterogeneity and small sample sizes. This study protocol aims to evaluate the efficacy of a Neurofeedback-Assisted Mindfulness Training Program (NAMTP) in adults with medium-to-high-frequency episodic migraine. Methods/design This is a randomized, parallel-group, controlled clinical trial protocol. Sixty-six ( N = 66) adults diagnosed with medium-to-high-frequency episodic migraine (5–14 monthly migraine days) will be recruited and randomized (1:1 ratio) into either the Intervention Group (IG: standard care plus NAMTP) or the Control Group (CG: standard routine care alone). The IG will undergo a 12-week home-based program consisting of 60 sessions (15–20 min each, 5 times per week) of mindfulness training assisted by the Muse® electroencephalography (EEG) headband. Assessments will be conducted at baseline, 12 weeks (post-intervention), and 24 weeks post-randomization. The powered primary outcome is the change in Monthly Migraine Days (MMDs). Secondary outcomes include migraine-associated disability (MIDAS), headache impact (HIT-6), sleep parameters (actigraphy and PSQI), quality of life (MSQ v.2), and mood symptoms (BDI-II and STAI-Y). Discussion This protocol addresses the urgent need for scalable, non-pharmacological therapies in migraine management. By combining objective neurophysiological monitoring with behavioral training within a rigorous randomized controlled framework, this trial will clarify whether NAMTP can reduce headache burden, optimize sleep patterns, and diminish affective distress. The findings are expected to provide standardized, actionable evidence regarding the integration of digital neurofeedback tools into routine clinical care for episodic migraine. Clinical Trial Registration: ClinicalTrials.gov NCT07661888.