Comparing EEG indicators to assess mindfulness therapy for migraine relief
Official title: High-Density EEG-MEG-wearable EEG: Comparison of Quantitative Electroencephalographic Indicators as Neurophysiological Markers of Effectiveness of Mindfulness Therapy in Addition to Standard Treatment in Patients With High-frequency Episodic Migraine
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06938178 · Data updated 2026-11-12
This study is testing if mindfulness therapy can help people with frequent migraines feel better by looking at brain activity and using wearable devices to track progress at home.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | April 23, 2024 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT06938178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with high-frequency episodic migraines who have stable therapy for at least three months prior to starting mindfulness treatment.
✕Probably not a fit
Patients with psychiatric comorbidities, secondary headache disorders, or those who have previously undergone mindfulness treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the effectiveness of mindfulness therapy as an adjunct treatment for patients suffering from high-frequency episodic migraines. By utilizing advanced neurophysiological monitoring techniques, including high-density EEG and MEG, the study seeks to identify specific indicators that correlate with the success of mindfulness interventions. Additionally, it will assess the feasibility of using wearable EEG devices for monitoring these indicators in a home setting. The ultimate goal is to enhance personalized treatment strategies for migraine sufferers based on identified neurophysiological markers.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized mindfulness interventions for patients with high-frequency episodic migraines.
How similar studies have gone: While mindfulness has shown promise in treating migraines in other studies, this specific approach using neurophysiological markers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients will be included who fulfil the ICHD-3 criteria \[8\] for HFEM, code 1.3-Chronic Migraine (characteristics similar to CM but with a frequency of 8-14 migraine days per month) with stable therapy in the 3 months prior to the start of Mindfulness treatment. If the therapy is changed during the screening visit, the patient will wait 3 months before starting Mindfulness treatment. Exclusion Criteria: * in the presence of psychiatric comorbidities in the psychotic area, reported in the history or assessed by the clinician * if pregnant * in the presence of secondary headache comorbidities (e.g. idiopathic intracranial hypertension) * if they have undergone symptomatic abuse detoxification at least twice in the previous two years * if they have already undergone any kind of treatment with Mindfulness or meditation techniques
Where it's running
-
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Italy Recruiting
Study contacts
- Principal investigator: Paola Lanteri, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: Paola Lanteri, MD
- Email: paola.lanteri@istituto-besta.it
- Phone: 02.2394.2538
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gepants for Acute Migraine in the Emergency Department
This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.
-
Neuropsychological and cognitive profile in adults with migraine
This project will test how thinking skills and psychological factors (like anxiety, depression, worry, and coping) relate to migraine in adults who have had migraine for at least one year.
-
Oral caffeine to reduce pain during acute migraine attacks
This test will see if a single 200 mg oral caffeine tablet taken during an acute migraine can reduce pain for adults with episodic or chronic migraine with or without aura.
-
Aerobic exercise to improve sensory, muscle, and psychosocial symptoms in women with migraine
This trial will test whether supervised aerobic exercise plus one pain neuroscience education session helps women aged 18–48 with migraine reduce disability and improve sensory, musculoskeletal, and psychosocial symptoms.
-
Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia
We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.
-
Elismetrep (K-304) for acute treatment of migraine
This study tests whether a single dose of elismetrep can quickly lessen the pain of a migraine compared with placebo in adults 18 to 75.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.