Effect of neurofeedback-assisted mindfulness training on migraine severity, associated disability, sleep quality, and emotional distress: protocol for a randomized controlled trial
9 affiliations
- 1Facultad de Enfermería y Fisioterapia, Universidad de Salamanca, Salamanca, Spain
- 2Facultad de Medicina, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
- 3Facultad de Enfermería y Fisioterapia, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Complejo Asistencial Universitario de Salamanca (CAUSA), Salamanca, Spain
- 4Facultad de Enfermería y Fisioterapia, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
- 5College of Humanities and Social Sciences, Graduate Institute of Humanities in Medicine, Taipei Medical University, Taipei, Taiwan
- 6Complejo Asistencial Universitario de Salamanca (CAUSA), Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
- 7Gerencia de Atención Primaria de Zamora, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
- 8College of Medicine, Graduate Institute of Clinical Psychology, Taipei Medical University, Taipei, Taiwan
- 9Facultad de Enfermería y Fisioterapia, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud (RICAPPS), Salamanca, Spain
Abstract
BackgroundMigraine 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/designThis 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).DiscussionThis 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.
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BibTeX
@article{zahrihaidar2026effect,
title = {{Effect of neurofeedback-assisted mindfulness training on migraine severity, associated disability, sleep quality, and emotional distress: protocol for a randomized controlled trial}},
author = {Chaimae Zahri-Haidar and Irene A. Garcia-Yu and Nerea Sanchez-Sanchez and Jesús Gonzalez-Sanchez and Hsin-Chien Lee and Victoria Alejos-Herrera and Virginia Iglesias-Sierra and Hsueh-Chen Lu and Jose I. Recio-Rodriguez},
journal = {Frontiers in Digital Health},
year = {2026},
month = oct,
doi = {10.3389/fdgth.2026.1962535},
url = {https://doi.org/10.3389/fdgth.2026.1962535},
note = {CC BY},
}
RIS
TY - JOUR
TI - Effect of neurofeedback-assisted mindfulness training on migraine severity, associated disability, sleep quality, and emotional distress: protocol for a randomized controlled trial
AU - Chaimae Zahri-Haidar
AU - Irene A. Garcia-Yu
AU - Nerea Sanchez-Sanchez
AU - Jesús Gonzalez-Sanchez
AU - Hsin-Chien Lee
AU - Victoria Alejos-Herrera
AU - Virginia Iglesias-Sierra
AU - Hsueh-Chen Lu
AU - Jose I. Recio-Rodriguez
PY - 2026
DA - 2026/10/26
JO - Frontiers in Digital Health
DO - 10.3389/fdgth.2026.1962535
UR - https://doi.org/10.3389/fdgth.2026.1962535
AB - BackgroundMigraine 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/designThis 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).DiscussionThis 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.
SN - 2673-253X
ER -