NCT07279623Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for 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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This is a prospective, randomized, open-label, delayed-start clinical investigation evaluating the safety and efficacy of the Walther System, a Class IIa investigational medical device delivering intra-nasal mechanical stimulation (INMEST), as a preventative treatment for migraine. A total of 110 adults (18-65 years) with a history of migraine will be randomized 1:1 into two groups: Group A (early treatment) and Group B (delayed treatment). The study includes baseline assessments, in-clinic device training, and home-based self-administered treatments every second day for six weeks. The primary outcome is the change in monthly migraine days during the primary treatment comparison period. Secondary outcomes include headache days, migraine intensity, duration, rescue medication use, patient-reported outcomes, device compliance, and safety. The study will be conducted at one site in Sweden.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 21 Oct 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Abilion Medical Systems AB
- Diseases
- Migraine
- NCT number
- NCT07279623
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 21 Oct 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recently (12 months prior screening) undergone nasal or sinus surgery.
- Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
Other illness
- 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.
Other
- Subject unable to distinguish between migraine headaches and other headache types.
- Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
- The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
Who the study is looking for
- Age 18-65 years at the time of screening.
- 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.
- Onset of migraine headache occurred before age 50.
- History of migraines for at least 1 year before screening.
- The study subject reports at least 8 monthly migraine days during the screening period.
- If subject is on a prophylactic migraine medication regimen:
- Reports stable medication regimen during the three months prior to screening.
- Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up.
- 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.
- Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
- Anticipated compliance with prescribed treatment and follow-up.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INMEST-mottagningen Odenplan Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.