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
Recruiting · NCT06938178 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Fondazione IRCCS Istituto Neurologico C. Besta - Milan, Italy