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
| NCT ID | NCT06938178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-23 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-04-23 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Paola Lanteri, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Frequently Asked Questions
Who can join the NCT06938178 clinical trial?
This trial is open to participants of all sexes, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938178 currently recruiting?
Yes, NCT06938178 is actively recruiting participants. Contact the research team at paola.lanteri@istituto-besta.it for enrollment information.
Where is the NCT06938178 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06938178 clinical trial?
NCT06938178 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The principal investigator is Paola Lanteri, MD at Fondazione IRCCS Istituto Neurologico Carlo Besta. The trial plans to enroll 40 participants.
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