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

NCT07279623 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

INMEST-treatment

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.

Sponsors & Collaborators

  • Aurevia

    collaborator INDUSTRY

  • Insamlingsstiftelsen för främjande av forskning avseende INMEST

    collaborator UNKNOWN

  • Abilion Medical Systems AB

    lead INDUSTRY

Principal Investigators

  • Jan-Erik Juto, PhD, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279623 on ClinicalTrials.gov