Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine

Sponsor
Abilion Medical Systems AB
Study ID
NCT07279623
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • INMEST-treatment — DEVICE
    Hand-held controller and catheter assembly for intra-nasal mechanical stimulation (INMEST), self-administered at home every second day for 6 weeks, first treatment under supervision.

Study Details

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.

Key Dates

First listed
Dec 12, 2025
Start date
Oct 21, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A - Early Start
    Subjects undergo a 4-week baseline assessment (weeks 1-4), then receive active treatment with the Walther System every second day for 6 weeks (weeks 5-10). The first treatment is performed under supervision at the clinic, and subsequent treatments are self-administered at home. Post-treatment assessments occur during weeks 11-14.
  • Active Comparator: Group B - Delayed Start
    Subjects undergo a 4-week baseline assessment (weeks 1-4), followed by a 6-week no-treatment reference period (weeks 5-10). Active treatment with the Walther System is then administered every second day for 6 weeks (weeks 11-16), starting with an initial supervised treatment at the clinic. Post-treatment assessments occur during weeks 17-20.

Primary Outcome Measure

Change in Monthly Migraine Days [ Time Frame: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period) ]

Central Contacts

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