Intra-nasal mechanical stimulation (INMEST) to prevent migraine
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine - A Prospective, Randomized, Open Label, Delayed-Start Study to Evaluate the Safety and Performance of the Walther System
This study will test whether intra-nasal mechanical stimulation (INMEST) given every other day can reduce monthly migraine days in adults with migraine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Abilion Medical Systems AB Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07279623 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label delayed-start investigation of a Class IIa device (the Walther System) that delivers intra-nasal mechanical stimulation as a preventive treatment for migraine. A total of 110 adults aged 18–65 with a clinical diagnosis of migraine will be randomized 1:1 to early treatment or delayed treatment groups, with in-clinic device training followed by home self-administration every second day for six weeks. The primary outcome is change in monthly migraine days during the primary treatment comparison period, and secondary outcomes include headache days, migraine intensity and duration, rescue medication use, patient-reported outcomes, device compliance, and safety. The study is conducted at a single site in Stockholm, Sweden.
Who should consider this trial
Good fit: Adults 18–65 with a confirmed clinical diagnosis of migraine (with or without aura) who have had migraines for at least one year and report at least 8 monthly migraine days are the intended candidates.
Not a fit: Patients with fewer than 8 monthly migraine days, migraine onset after age 50, unstable prophylactic medication regimens, or those unable or unwilling to attend site visits or perform home treatments are unlikely to benefit.
Why it matters
Potential benefit: If successful, INMEST could reduce the number of migraine days and decrease headache severity and need for rescue medication.
How similar studies have performed: Related noninvasive neuromodulation methods (for example noninvasive vagus nerve stimulation and transcranial magnetic stimulation) have shown benefits for some patients, but intra-nasal mechanical stimulation (INMEST) is a novel and relatively untested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 years at the time of screening. 2. The study subject must have a clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-3), indicated by medical record shown by the subject. 3. Onset of migraine headache occurred before age 50. 4. History of migraines for at least 1 year before screening. 5. The study subject reports at least 8 monthly migraine days during the screening period. 6. If subject is on a prophylactic migraine medication regimen: 1. Reports stable medication regimen during the three months prior to screening. 2. Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up. 7. The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments. 8. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study. 9. Anticipated compliance with prescribed treatment and follow-up. Exclusion Criteria: 1. Subject unable to distinguish between migraine headaches and other headache types. 2. Recently (12 months prior screening) undergone nasal or sinus surgery. 3. Any severe diseases for which, in the opinion of the Investigator, participation would not be in the best interest of the subject or that can interfere with the performance, evaluation, and outcome of the clinical evaluation. 4. Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s. 5. Subject is pregnant or lactating or planning to get pregnant during the duration of the study. 6. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation. 7. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
Where this trial is running
Stockholm
- INMEST-mottagningen Odenplan — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Jan-Erik Juto, PhD, MD
- Study coordinator: Karl-Johan Pantzar, MSc, MSc
- Email: kj@abilion.com
- Phone: +46(0)739808065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.