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Long-term follow-up for chronic migraine treatment using intranasal kinetic oscillation

An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

Not applicable Interventional Chordate Medical · NCT05843721

This study is testing if a new nasal treatment can help people with chronic migraines feel better over a year while they keep taking their usual medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorChordate Medical Industry-sponsored
Drugs / interventionsradiation
Locations16 sites (Dresden and 15 other locations)
Trial IDNCT05843721 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the long-term effects of intranasal kinetic oscillation stimulation on patients suffering from chronic migraines. Eligible participants will maintain a daily diary for four weeks to record their headache and migraine days, which will serve as baseline data. Following this period, subjects will receive up to 14 treatments over a 12-month follow-up, while continuing their existing migraine medications. The study aims to assess symptom improvement in a multi-center setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of chronic migraine experiencing at least 15 headache days per month.

Not a fit: Patients with migraines that do not meet the chronic criteria or those who have not experienced migraines for at least one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraine attacks for patients.

How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in treating chronic migraines with innovative methods.

Eligibility criteria

Show full inclusion / exclusion criteria 
INCLUSION AND EXCLUSION CRITERIA:

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 70 years (inclusive) at the time of providing informed consent;
3. Diagnosed with 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 65 years;
5. Reported history of migraine for at least 1 year before screening;
6. Able and willing to maintain current prophylactic migraine medication regimen (if any) (no change in type, frequency or dose) from screening to at least the 6-month follow-up;
7. 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 headache and other headache types;
2. An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
3. Nasal cavity abnormalities that prevents catheter insertion.
4. A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
5. A known allergy to polyurethane (polyurethane is used in the catheter balloon).
6. Systemic diseases with manifestations in the nose.
7. Previous treatment with radiation therapy to the nasal area.
8. Nasal surgery performed within the last six months.
9. 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;
10. Pregnant and lactating women;
11. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
12. Previous participation in this study;
13. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.

Only at baseline visit (day 0) If subject missed \>4 days of eDiary entry, subject will be withdrawn.

Where this trial is running

Dresden and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.