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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness treatment.
- Who it may be relevant to
- Registry conditions: Migraine, Migraine Disease, High Frequency Episodic Migraine. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Mindfulness treatment
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 me
Primary outcome measures
- Correlation between neurophysiological indicators and clinical outcome [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (2)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico C. Besta — Milan
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. PMID 31082635
- 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. PMID 37452281
- 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. PMID 35788839
- 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. PMID 32845485
- 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. PMID 31557329
- 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. PMID 26526604
- 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. PMID 34160823
Identifiers
NCT: NCT06938178 · MindMEEG