Episodic Migraine
Conditions
Keywords
neurofeedback, episodic migraine, migraine frequency, migraine severity, sleep quality, disability, quality of life
Brief summary
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.
Interventions
BEHAVIORALNeurofeedback
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.
Sponsors
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in migraine frequency at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | Number of migraine days per month |
| Change from baseline in migraine severity at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | 4-point scale: Zero is equivalent to no headache, 1 indicates mild headache, 2 indicates moderate headache, and 3 indicates severe headache. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in disability at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | The validated Spanish version of the Migraine Disability Assessment Questionnaire (MIDAS) will be administered. This questionnaire consists of seven items; the first five items form the main scale, while items six and seven refer, respectively, to headache frequency and intensity. |
| Change from baseline in impact on daily life at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | It will be evaluated using the The Headache Impact Test (HIT-6) whose Spanish version has shown psychometric properties equivalent to the original English version. |
| Change from baseline in sleep quality at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | The Pittsburgh Sleep Quality Index (PSQI) will be administered. It consists of 19 items that generate seven component scores. Each component is rated from 0 to 3, where lower scores indicate no difficulty and higher scores indicate greater impairment. The sum of these components yields a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. |
| Change from baseline in quality of life at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | It will be assessed using the Migraine-Specific Quality of Life Questionnaire (MSQ) version 2. This instrument consists of 14 items with six response options ranging from "None of the time" to "All of the time." Each of the three MSQ domains is scored independently and transformed into a linear scale from 0 to 100, where higher scores indicate better health status. |
| Change from baseline in depressive symptoms at 12 and 24 weeks | Baseline, 12 weeks, and 24 weeks | Assessed using the Patient Health Questionnaire-9 (PHQ-9), a nine-item self-report instrument that evaluates depressive symptoms based on DSM-IV criteria for major depressive disorder, (score 0-27), higher scores indicate greater severity of depressive symptoms. |
Countries
Spain
Contacts
CONTACTJosé I Recio Rodríguez
Outcome results
None listed