High Frequency Episodic Migraine, Migraine, Migraine Disease
Conditions
Keywords
Migraine, MEG, Mindfulness, Wearable EEG
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.
Interventions
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.
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between neurophysiological indicators and clinical outcome | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between neurophysiological indicators calculated with different types of device | through study completion, an average of 2 years | 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) |
| Correlation between neurophysiological indicators and neuropsychological scores | through study completion, an average of 2 years | 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) |
Countries
Italy
Contacts
CONTACTPaola Lanteri, MD
CONTACTElisa Visani, ENG
PRINCIPAL_INVESTIGATORPaola Lanteri, MD
Fondazione IRCCS Istituto Neurologico Carlo Besta
Outcome results
None listed