Clinical trial NCT06938178: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Migraine Disease
High Frequency Episodic Migraine
Keywords: Migraine
MEG
Mindfulness
Wearable EEG
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Correlation between neurophysiological indicators and clinical outcome
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Correlation between neurophysiological indicators calculated with different types of device
timeFrame: through study completion, an average of 2 years
measure: Correlation between neurophysiological indicators and neuropsychological scores
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Paola Lanteri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grazzi 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.
citation: Grazzi 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.
citation: Sansone 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.
citation: Seng 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.
citation: Harris 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.
citation: Ailani 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.