Episodic MigraineNCT07661888
Neurofeedback for Episodic Migraine
A study testing Neurofeedback in people with Episodic Migraine, run by University of Salamanca at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
University Hospital of Salamanca
Salamanca, Salamanca, 37007
José I Recio Rodríguez, +34 923294500 ext. 3108, donrecio@usal.es
About this study
Official title: Effectiveness of Neurofeedback for Reducing the Frequency and Severity of Episodic Migraine
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.
Read more
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.
- Conditions
- Episodic Migraine
- Being tested
- Neurofeedback
- Keywords
- neurofeedback, episodic migraine, migraine frequency, migraine severity, sleep quality, disability, quality of life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
Also called Biofeedback
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Neurofeedback Receives: Behavioral: Neurofeedback |
| Control group | No intervention | Group control will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in migraine frequency at 12 and 24 weeks
Number of migraine days per month
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Ignacio Recio Rodriguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661888
- Sponsor's protocol ID
- PI2025071951
- Status last verified
- May 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available upon reasonable request, subject to approval by the principal investigator and a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neurofeedback for Reducing the Frequency and Severity of Episodic Migraine
- ClinicalTrials.gov ID
- NCT07661888
- Acronym / sponsor ID
- PI2025071951
- Conditions
- Episodic Migraine
- Keywords
- neurofeedback, episodic migraine, migraine frequency, migraine severity, sleep quality, disability, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: NeurofeedbackNeurofeedback |
| Control group | No intervention | –Group control will not receive any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: BiofeedbackThe 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. | Behavioural | Intervention group |
Primary outcome
Change from baseline in migraine frequency at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Number of migraine days per month
Change from baseline in migraine severity at 12 and 24 weeks
Time frame: 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.
5 secondary outcomes
Change from baseline in disability at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in impact on daily life at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in sleep quality at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in quality of life at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Change from baseline in depressive symptoms at 12 and 24 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available upon reasonable request, subject to approval by the principal investigator and a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Episodic Migraine, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José I Recio Rodríguez (+34 923294500 ext. 3108, donrecio@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in migraine frequency at 12 and 24 weeks (time frame: Baseline, 12 weeks, and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.