An interventional study of Neurofeedback in Episodic Migraine, sponsored by University of Salamanca. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 66 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neurofeedback
Behavioral: Neurofeedback
Group control will not receive any intervention
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.
Also known as: Biofeedback
Change from baseline in migraine frequency at 12 and 24 weeks
Number of migraine days per month
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in migraine severity at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in disability at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in impact on daily life at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in sleep quality at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in quality of life at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in depressive symptoms at 12 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.
Time frame: Baseline, 12 weeks, and 24 weeks
Plan to share: Yes — Deidentified individual participant data will be made available upon reasonable request, subject to approval by the principal investigator and a data sharing agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 8 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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