Comparing EEG indicators to assess mindfulness therapy for migraine relief
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
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06938178 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with psychiatric comorbidities, secondary headache disorders, or those who have previously undergone mindfulness treatment may not benefit from this study.
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 performed: While mindfulness has shown promise in treating migraines in other studies, this specific approach using neurophysiological markers is relatively novel.
Eligibility criteria
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 this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.