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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04194008
Eligibility Criteria:
Inclusion Criteria:
1. Participants aged 18-75 years old.
2. Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
3. Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
4. Participants have personal access to a smartphone
5. Participants must be able and willing to comply with the protocol
6. Participants must be able and willing to provide written informed consent
Exclusion Criteria:
1. Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
2. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
3. Participants with uncontrolled epilepsy.
4. Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
5. Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
6. Pregnant, trying to get pregnant or breastfeeding female participants
7. Subjects participating in any other interventional clinical study.
8. Participants without basic cognitive and/or motor skills needed to operate a smartphone
9. Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
10. Participants who have previous experience with the device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04194008
Study Brief:
Protocol Section:
NCT04194008