Neurofeedback for Episodic Migraine

NCT07661888 | Not Yet Recruiting

• 1 other identifier: PI2025071951
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Episodic Migraine

Keywords

neurofeedback; episodic migraine; migraine frequency; migraine severity; sleep quality; disability; quality of life

Outcome Measures

Primary Outcomes (2)

• Change from baseline in migraine frequency at 12 and 24 weeks

  Number of migraine days per month

  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.

  Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (5)

• Change from baseline in disability at 12 and 24 weeks

  Baseline, 12 weeks, and 24 weeks

• Change from baseline in impact on daily life at 12 and 24 weeks

  Baseline, 12 weeks, and 24 weeks

• Change from baseline in sleep quality at 12 and 24 weeks

  Baseline, 12 weeks, and 24 weeks

• Change from baseline in quality of life at 12 and 24 weeks

  Baseline, 12 weeks, and 24 weeks

• Change from baseline in depressive symptoms at 12 and 24 weeks

  Baseline, 12 weeks, and 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Neurofeedback

Behavioral: Neurofeedback

Control group

NO INTERVENTION

Group control will not receive any intervention

Interventions

Neurofeedback BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University Hospital of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Neurofeedback; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

José I Recio Rodríguez

CONTACT

+34 923294500; donrecio@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)