MigraineMindMEEGNCT06938178
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
An observational study of Migraine and Migraine Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine, Migraine Disease, High Frequency Episodic Migraine
- What is being tested?
- Mindfulness treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2024to 31 Dec 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients will be included who fulfil the ICHD-3 criteria for high-frequency migraine (8-14 migraine days per month) with stable therapy in the 3 months prior to study participation. If the therapy is changed during the screening visit, the patient will wait 3 months before being included in the study. Patients will be excluded in 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 and if they have already undergone any kind of treatment with Mindfulness or meditation techniques
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, 20133
Paola Lanteri, MD, 02.2394.2538, paola.lanteri@istituto-besta.it
About this study
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.
- Conditions
- Migraine, Migraine Disease, High Frequency Episodic Migraine
- Being tested
- Mindfulness treatment
- Keywords
- Migraine, MEG, Mindfulness, Wearable EEG
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness treatmentOther
The Mindfulness treatment will consist of a series of 8 weekly meetings in small groups . An experienced therapist will guide patients and during the sessions they will be encouraged to close their eyes, assume a relaxed posture, focus on breathing and the present moment in order to improve awareness of mental and bodily sensations. Patients will also be encouraged to add a regular, practice at home of about 10 minutes to the group treatment. If necessary, patients in both groups can take the medication they normally take for acute events. These occurrences will be reported in the headache diary given to each subject. Before conducting the study protocol, the investigator will explain the study to each participant and collect a signed copy of the written informed consent. All participants will undergo a clinical, neurophysiological and neuropsychological evaluation before the first session and after the last. In both groups, the usual drug therapies in case of crisis will be allowed.
| Study group | Role | What they receive |
|---|---|---|
| Group Mindfulness treatment | group undergoing 8 weeks of Mindfulness treatment and unchanged drug therapy Receives: Other: Mindfulness treatment | |
| Group Standard of care | group re-evaluated after 8 weeks without any additional intervention and with unchanged drug therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between neurophysiological indicators and clinical outcome
The primary endpoint is the correlation between change in quantitative neurophysiological indices from MEG and hdEEG and change in attack characteristics (monthly frequency, intensity, duration, and use of symptomatic medication) of migraine without aura after treatment with Mindfulness. Quantitative indices of brain activity will include frequency and amplitude of the peaks in the canonical bands (delta: 1-4 Hz, theta: 4-8 Hz, alpha: 8-12 Hz, beta: 13-30 Hz), relative power in the canonical bands, power ratio (DAR: delta/alpha power ratio; DTABR: (delta + theta)/(alpha + beta) power ratio, BSI: brain symmetric index).
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
Correlation between neurophysiological indicators calculated with different types of device
A secondary outcome is the correlation between the quantitative neurophysiological indices (frequency and amplitude of peaks and relative power in canonical bands, DAR, DTABR, BSI) obtained from signals acquired with clinical high-density instrumentation (hdEEG and MEG) and the same indices obtained from signals acquired with low-density instrumentation (wEEG)
Measured: through study completion, an average of 2 years
Correlation between neurophysiological indicators and neuropsychological scores
A secondary outcome is the correlation between variation in quantitative neurophysiological indices (frequency and amplitude of peaks and relative power in canonical bands, DAR, DTABR, BSI) assessed with both high-density and low-density instrumentations and variation in neuropsychological test scores (Migraine-Specific Quality of Life Questionnaire 2.1, Pain Catastrophizing Scale, General Self Efficacy Scale, Mindful Attention Awareness Scale, Multidimensional Assessment of Interoceptive Awareness, Beck Depression Inventory II, State-Trait Anxiety Inventory-Y)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start23 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Lanteri, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938178
- Sponsor's protocol ID
- MindMEEG
- Acronym
- MindMEEG
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang YY, Tang R, Rothbart MK, Posner MI. Frontal theta activity and white matter plasticity following mindfulness meditation. Curr Opin Psychol. 2019 Aug;28:294-297. doi: 10.1016/j.copsyc.2019.04.004. Epub 2019 Apr 18.
PubMed 31082635Grazzi L, D'Amico D, Guastafierro E, Demichelis G, Erbetta A, Fedeli D, Nigri A, Ciusani E, Barbara C, Raggi A. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023 Jul 14;24(1):86. doi: 10.1186/s10194-023-01630-0.
PubMed 37452281Grazzi L, Montisano DA, Raggi A, Rizzoli P. Feasibility and effect of mindfulness approach by web for chronic migraine and high-frequency episodic migraine without aura at in adolescents during and after COVID emergency: preliminary findings. Neurol Sci. 2022 Sep;43(9):5741-5744. doi: 10.1007/s10072-022-06225-2. Epub 2022 Jul 4.
PubMed 35788839Sansone E, Grazzi L, Raggi A, Leonardi M, D'Amico D. Mindfulness as an add-on treatment for patients with chronic migraine and medication overuse: a preliminary analysis. Neurol Sci. 2020 Dec;41(Suppl 2):469-471. doi: 10.1007/s10072-020-04662-5. No abstract available.
PubMed 32845485Seng EK, Singer AB, Metts C, Grinberg AS, Patel ZS, Marzouk M, Rosenberg L, Day M, Minen MT, Lipton RB, Buse DC. Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial. Headache. 2019 Oct;59(9):1448-1467. doi: 10.1111/head.13657. Epub 2019 Sep 26.
PubMed 31557329Harris P, Loveman E, Clegg A, Easton S, Berry N. Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults. Br J Pain. 2015 Nov;9(4):213-24. doi: 10.1177/2049463715578291.
PubMed 26526604Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153. Epub 2021 Jun 23.
PubMed 34160823
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06938178
- Acronym / sponsor ID
- MindMEEG / MindMEEG
- Conditions
- Migraine, Migraine Disease, High Frequency Episodic Migraine
- Keywords
- Migraine, MEG, Mindfulness, Wearable EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Mindfulness treatment | – | Other: Mindfulness treatmentgroup undergoing 8 weeks of Mindfulness treatment and unchanged drug therapy |
| Group Standard of care | – | –group re-evaluated after 8 weeks without any additional intervention and with unchanged drug therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients will be included who fulfil the ICHD-3 criteria for high-frequency migraine (8-14 migraine days per month) with stable therapy in the 3 months prior to study participation. If the therapy is changed during the screening visit, the patient will wait 3 months before being included in the study. Patients will be excluded in 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 and if they have already undergone any kind of treatment with Mindfulness or meditation techniques
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Mindfulness treatmentThe Mindfulness treatment will consist of a series of 8 weekly meetings in small groups . An experienced therapist will guide patients and during the sessions they will be encouraged to close their eyes, assume a relaxed posture, focus on breathing and the present moment in order to improve awareness of mental and bodily sensations. Patients will also be encouraged to add a regular, practice at home of about 10 minutes to the group treatment. If necessary, patients in both groups can take the medication they normally take for acute events. These occurrences will be reported in the headache diary given to each subject. Before conducting the study protocol, the investigator will explain the study to each participant and collect a signed copy of the written informed consent. All participants will undergo a clinical, neurophysiological and neuropsychological evaluation before the first session and after the last. In both groups, the usual drug therapies in case of crisis will be allowed. | Other | Group Mindfulness treatment |
Primary outcome
Correlation between neurophysiological indicators and clinical outcome
Time frame: through study completion, an average of 2 years
The primary endpoint is the correlation between change in quantitative neurophysiological indices from MEG and hdEEG and change in attack characteristics (monthly frequency, intensity, duration, and use of symptomatic medication) of migraine without aura after treatment with Mindfulness. Quantitative indices of brain activity will include frequency and amplitude of the peaks in the canonical bands (delta: 1-4 Hz, theta: 4-8 Hz, alpha: 8-12 Hz, beta: 13-30 Hz), relative power in the canonical bands, power ratio (DAR: delta/alpha power ratio; DTABR: (delta + theta)/(alpha + beta) power ratio, BSI: brain symmetric index).
2 secondary outcomes
Correlation between neurophysiological indicators calculated with different types of device
Time frame: through study completion, an average of 2 years
Correlation between neurophysiological indicators and neuropsychological scores
Time frame: through study completion, an average of 2 years
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 1 Sep 2026.
- Background: PubMed 31082635Tang YY, Tang R, Rothbart MK, Posner MI. Frontal theta activity and white matter plasticity following mindfulness meditation. Curr Opin Psychol. 2019 Aug;28:294-297. doi: 10.1016/j.copsyc.2019.04.004. Epub 2019 Apr 18.
- Background: PubMed 37452281Grazzi L, D'Amico D, Guastafierro E, Demichelis G, Erbetta A, Fedeli D, Nigri A, Ciusani E, Barbara C, Raggi A. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023 Jul 14;24(1):86. doi: 10.1186/s10194-023-01630-0.
- Background: PubMed 35788839Grazzi L, Montisano DA, Raggi A, Rizzoli P. Feasibility and effect of mindfulness approach by web for chronic migraine and high-frequency episodic migraine without aura at in adolescents during and after COVID emergency: preliminary findings. Neurol Sci. 2022 Sep;43(9):5741-5744. doi: 10.1007/s10072-022-06225-2. Epub 2022 Jul 4.
- Background: PubMed 32845485Sansone E, Grazzi L, Raggi A, Leonardi M, D'Amico D. Mindfulness as an add-on treatment for patients with chronic migraine and medication overuse: a preliminary analysis. Neurol Sci. 2020 Dec;41(Suppl 2):469-471. doi: 10.1007/s10072-020-04662-5. No abstract available.
- Background: PubMed 31557329Seng EK, Singer AB, Metts C, Grinberg AS, Patel ZS, Marzouk M, Rosenberg L, Day M, Minen MT, Lipton RB, Buse DC. Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial. Headache. 2019 Oct;59(9):1448-1467. doi: 10.1111/head.13657. Epub 2019 Sep 26.
- Background: PubMed 26526604Harris P, Loveman E, Clegg A, Easton S, Berry N. Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults. Br J Pain. 2015 Nov;9(4):213-24. doi: 10.1177/2049463715578291.
- Background: PubMed 34160823Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153. Epub 2021 Jun 23.
- Individual participant dataSharing planned: No
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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.
Paola Lanteri, MD principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Sep 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 Italy. 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 Paola Lanteri, MD (02.2394.2538, paola.lanteri@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between neurophysiological indicators and clinical outcome (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938178, which also lists 7 linked publications.
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 1 Sep 2026.