Chronic Migraine Headache
Conditions
Brief summary
Clinical exploration of NEUROMARK System in Participants with Chronic Migraine
Interventions
DEVICENEUROMARK System
NEUROMARK System for Chronic Migraine
Sponsors
Neurent Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Must: * Be ≥18 years of age. * Have Chronic Migraine * Be willing and able to comply with all study elements, as indicated by written informed consent.
Exclusion criteria
Participant Must Not: * Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction. * Progressive neurologic disorder other than migraine. * Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor. * Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study. * Have had previous sinus or nasal surgery within 6 months of study enrollment. * Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis. * Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized. * Have an acute nasal or sinus infection. * Have nasal mucosal erosion/ulceration. * Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure. * Have hemophilia. * Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. * Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity. * Have had previous head and/or neck irradiation. * Be pregnant. * Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the participant at risk, could confound the study results, or may interfere significantly with the participant's participation in the study. * Be participating in another clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Monthly Migraine Headache Days | 6 months | Monthly headache logs were used to record headache frequency, intensity, duration, and pain. Mean change from baseline in number of migraine headache days per month was assessed over 6 months. |
Countries
United States
Outcome results
None listed