Actively Recruiting

All Genders
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

Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2025-04-22

40

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients fulfilling ICHD-3 criteria for high-frequency episodic migraine with 8-14 migraine days per month
  • Stable migraine therapy for at least 3 months before starting Mindfulness treatment
  • If therapy changed during screening, patient must wait 3 months before starting treatment
Not Eligible

You will not qualify if you...

  • Presence of psychiatric comorbidities in the psychotic area
  • Pregnant patients
  • Secondary headache comorbidities such as idiopathic intracranial hypertension
  • History of symptomatic abuse detoxification at least twice in the past two years
  • Previous treatment with Mindfulness or meditation techniques

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Italy, 20133

Actively Recruiting

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Research Team

P

Paola Lanteri, MD

CONTACT

E

Elisa Visani, ENG

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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