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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00205894
Eligibility Criteria:
Inclusion Criteria:
1. Be diagnosed with chronic migraine, probable chronic migraine, and/or chronic cluster headache according to the 2004 IHS Classification Criteria (2nd ed.) or be diagnosed with migraine with or without aura
2. Be 18 years of age or older
3. Be willing and able to follow all study-related procedures during the course of the study;
4. Have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventative classes.
Exclusion Criteria:
1. Have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days;
2. Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade currently in effect;
3. Have had a previous surgery in the intended implant area;
4. Have Arnold-Chiari malformation;
5. Have participated within the last 30 days or plan to participate within the next 4 months in a device or drug trial;
6. Be pregnant or planning on becoming pregnant during the study period;
7. Have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy; and
8. Currently require, or be likely to require, MRI or diathermy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00205894
Study Brief:
Protocol Section:
NCT00205894