A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine

This is an interventional prevention trial for Chronic Migraine Read More

Inclusion Criteria:

1. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form;
2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
3. Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
4. Migraine onset before the age of 50 years;
5. Reported history of migraine for at least 1 year before screening;
6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
8. Failed at least 3 different preventive medications and 3 months of treatment with a monoclonal antibody targeting the CGRP pathway;
9. Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate <1% per year when used consistently and correctly) during the study.

Exclusion Criteria:

1. Unable to distinguish between migraine and other headache types;
2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
3. Ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
4. Treatment with non-invasive neuromodulation technique in the past, such as for example nVNS or sTMS < 1 month before screening visit;
5. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
6. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid rhinorrhea;
7. Fitted with a pacemaker/defibrillator;
8. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
9. Ongoing upper respiratory infection or malignancy in the nasal cavity;
10. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
11. Head injury or open wound that contraindicates use of the Chordate Headband;
12. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
13. Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;
14. Pregnant and lactating women;
15. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
16. Previous participation in this study;
17. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals;
18. Patients who has not been fully vaccinated for SARS-CoV-2;
19. Use of opioid containing analgesics on more than 4 days per month.