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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT03398668
Eligibility Criteria:
Inclusion Criteria:
1. Males and females Ages of 18 to 65 years old.
2. History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
3. Capable to corporate with the study protocol and to sign an informed consent.
Exclusion Criteria:
1. Patients having received Botox treatment in the head region in the prior 4 months.
2. Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
3. History of Medication Overuse Headache.
4. Patients using opioid medication.
5. Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
6. Implanted metal or electrical devices in the head (not including dental implants).
7. Patient having had a previous experience with the Relievion™ device.
8. Patients who have concomitant epilepsy.
9. History of neurosurgical interventions.
10. Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
11. History of drug abuse or alcoholism.
12. Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
13. Skin lesion or inflammation at the region of the stimulating electrodes.
14. Personality or somatoform disorder.
15. Pregnancy or Lactation.
16. Women with child bearing potential without medically acceptable method of contraception.
17. History of cerebrovascular event.
18. Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
19. Patients using Cannabis
20. Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03398668
Study Brief:
Protocol Section:
NCT03398668