Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary High Frequency Episodic Migraine Migraine Disease Migraine Disorders Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, 20133, Italy

Location status: Recruiting

Location contact

Paola Lanteri, MD

CONTACT

[email protected]

02.2394.2538

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness treatment

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Correlation between neurophysiological indicators calculated with different types of device

    Time frame: 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)

  2. Correlation between neurophysiological indicators and neuropsychological scores

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Visani, ENG

CONTACT

[email protected]

02.2394.2538

Paola Lanteri, MD

CONTACT

[email protected]

02.2394.2538

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Acronym: MindMEEG

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.