Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04968093
Eligibility Criteria:
Inclusion criteria: one of the two main diagnoses are to me met.
1. diagnosis of episodic migraine without aura (code 1.1 of International Classification of Headache Disorders, third version - ICHD-3) at high frequency (HFEM).
The clinical features are those of code 1.1 of the ICHD-3, with headache lasting 2-72 hours (which is specific to populations aged \<18) and with frequency 8-14 days/month for \>3 months.
2. Diagnosis of Chronic Migraine (CM) (code 1.3 of International Classification of Headache Disorders, third version). Core features are the following:
* Headache (migraine-like or tension-type-like1) on 15 days/month for \>3 months
* Headache occurring in a patient who has had at least five attacks fulfilling criteria for Migraine without aura OR for Migraine with aura
* Headache with migraine-like features for at least 8 days/month for \>3 months, i.e. with typical features of migraine with or without aura, or with the headache believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative
Exclusion Criteria:
1. major psychiatric disorders based on clinical history;
2. psychotherapy of any approach in the previous 18 months;
3. previous experience of mindfulness or meditation approach
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04968093
Study Brief:
Protocol Section:
NCT04968093