Status:

RECRUITING

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

Lead Sponsor:

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

Conditions:

Migraine

Migraine Disease

Eligibility:

All Genders

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 pathophysiologica...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 23 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06938178

Start Date

April 23 2024

End Date

June 1 2026

Last Update

April 22 2025

Active Locations (1)

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Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Italy, 20133