Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

Exclusion Criteria

• •1. Unable to distinguish between migraine headaches 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. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
• •4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
• •5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
• •6. Fitted with a pacemaker/defibrillator;
• •7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
• •8. Ongoing upper respiratory infection or malignancy in the nasal cavity;
• •9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
• •10. Head injury or open wound that contraindicates use of the Chordate Headband;
• •11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
• •12. 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;
• •13. Pregnant and lactating women;
• •14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
• •15. Previous participation in this study;
• •16. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.