Studies brain wave markers of mindfulness therapy in frequent episodic migraine
Compares brain activity measures in adults with frequent migraine receiving mindfulness therapy plus standard care.
Key facts
- Who runs it
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Where
- Milan, ItalySee the site
- Trial code
- Registry 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
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 23 Apr 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Mindfulness treatment
- Record updated
- 1 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with migraine on 8 to 14 migraine days a month, on stable treatment, who will add Mindfulness therapy.
- Age
- Adults (no exact age range is given in the record).
- Sex
- All sexes can join.
- Disease stage
- High-frequency episodic migraine (ICHD-3 code 1.3), with 8-14 migraine days per month.
- Earlier treatment
- Stable migraine therapy for the 3 months before Mindfulness starts. No earlier Mindfulness or meditation treatment of any kind.
Main reasons for not taking part
- Psychotic-area psychiatric conditions, in the history or found by the clinician
- Pregnancy
- Other (secondary) headache conditions, for example idiopathic intracranial hypertension
- Symptomatic abuse detoxification at least twice in the past two years
- Any earlier Mindfulness or meditation treatment
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- in the presence of psychiatric comorbidities in the psychotic area, reported in the history or assessed by the clinician
- in the presence of secondary headache comorbidities (e.g. idiopathic intracranial hypertension)
- if pregnant
Where in Italy
- Fondazione IRCCS Istituto Neurologico C. BestaMilan, ItalyContact: Paola Lanteri, MDTaking people
About the trial
What the trial wants to find out
Recent studies suggest that Mindfulness may be an effective treatment for migraine, reducing the frequency of attacks, depression, anxiety and improving quality of life. However, the pathophysiological mechanisms underlying the effectiveness are not yet fully known. The identification of neurophysiological markers may help to better understand the mechanisms on which Mindfulness acts in migraine sufferers and to develop increasingly targeted and personalized Mindfulness interventions to optimize migraine treatment. The main objective of the study is to identify neurophysiological indicators of effectiveness of Mindfulness treatment in patients with migraine without high-frequency aura with clinically available devices (MEG and hdEEG). Another goal is to recognize the indicators also in the signal acquired with wearable devices in home use (wEEG). Finally, another goal will be to study the relationship between the identified neurophysiological markers and the change in neuropsychological test scores.
The 2 groups in the trial
- Group Mindfulness treatment
group undergoing 8 weeks of Mindfulness treatment and unchanged drug therapy
Treatment: Mindfulness treatment
- Group Standard of care
group re-evaluated after 8 weeks without any additional intervention and with unchanged drug therapy.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Studies brain wave markers of mindfulness therapy in frequent episodic migraineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 September 2026