Background:

Migraine is a highly prevalent neurological disorder and one of the leading causes of disability worldwide, particularly among women of reproductive age. It is associated with substantial clinical, psychological, and socioeconomic burden, including increased risk of vascular and psychiatric comorbidities, reduced quality of life, sleep disturbances, and decreased productivity. Neurofeedback (NF) has emerged as a promising non-pharmacological intervention aimed at promoting self-regulation of brain activity through real-time feedback and neuroplasticity mechanisms.

Objective:

This study aims to evaluate the effectiveness of neurofeedback as an adjunct therapy in reducing the frequency and severity of high-frequency episodic migraine in adults. Secondary objectives include assessing changes in medication use, sleep quality, disability and functional impact, depressive symptoms, and the influence of common migraine triggers.

Methods:

A randomized controlled trial with two parallel groups will be conducted at the University Hospital of Salamanca. Participants will be adults (>18 years) diagnosed with episodic migraine (5-14 days/month). A total of 66 participants will be randomly assigned (1:1) to either a neurofeedback intervention group or a control group. The intervention consists of 60 neurofeedback sessions over 12 weeks, including EEG-based training aimed at reducing high beta activity (21-30 Hz) and increasing alpha activity (8-12 Hz), as well as blood volume pulse biofeedback. The control group will receive no additional intervention. Primary outcomes include migraine frequency and severity, while secondary outcomes encompass medication use, disability (MIDAS, HIT-6), sleep quality (PSQI), quality of life (MSQ), depressive symptoms (PHQ-9), and trigger-related variables. Assessments will be performed at baseline, 3 months, and 6 months. Data will be analyzed using repeated-measures mixed models (SPSS v28).

Expected Results:

It is hypothesized that neurofeedback will significantly reduce migraine frequency and severity compared to control conditions, and improve associated functional, psychological, and sleep-related outcomes.

Conclusions:

This trial aims to provide robust evidence on the efficacy of neurofeedback as a complementary therapeutic approach for migraine, addressing the current need for well-designed randomized controlled studies in this field.

Inclusion Criteria:

• Adults aged ≥18 years
• Diagnosis of episodic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura.
• History of medium to high-frequency episodic migraine, defined as 5-14 migraine days per month during the 3 months prior to enrollment.
• Ability and willingness to provide written informed consent.

Exclusion Criteria:

• Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), defined as ≥15 headache days per month for more than 3 months, with at least 8 migraine days per month.
• History of severe psychiatric disorders (e.g., schizoaffective disorder, bipolar disorder, major depressive episode with psychotic features, or other non-organic psychotic disorders) requiring psychiatric treatment within the 6 months prior to enrollment.
• History of brain injury or other neurological conditions that contraindicate the use of neurofeedback.

Deidentified individual participant data will be made available upon reasonable request, subject to approval by the principal investigator and a data sharing agreement.