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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05730556
Eligibility Criteria:
Inclusion Criteria:
* Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.
* Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.
* Patient is willing and able to comply with the protocol to the satisfaction of the investigator.
* Patient has the capacity to provide written, informed consent for themselves.
Exclusion Criteria:
* Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).
* Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
* Participants with uncontrolled epilepsy.
* Pregnant, trying to get pregnant or breastfeeding female participants.
* Subjects participating in any other interventional clinical study.
* Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
* Participants who have previous experience with the device.
* Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.
* Patients receiving concurrent nerve blocks or trigger point injections within the same visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05730556
Study Brief:
Protocol Section:
NCT05730556