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NCT Number: NCT07279623

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INMEST-mottagningen Odenplan

Stockholm, 11327, Sweden

Location status: Recruiting

Location contact

Jan-Erik Juto, PhD, MD

CONTACT

[email protected]

+46(8)41400590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Subject unable to distinguish between migraine headaches and other headache types.
  • Recently (12 months prior screening) undergone nasal or sinus surgery.
  • 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.
  • Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
  • 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.

Treatment and study plan

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.

Other names: Walther System

Primary outcomes

  1. Change in Monthly Migraine Days

    Time frame: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)

    Between-group comparison of the difference in mean change in monthly migraine days from the baseline assessment period (weeks 1-4) to Group A) Treatment performance period (weeks 7-10) and Group B) No treatment reference period (weeks 7-10).

Secondary outcomes

  1. Mean change in monthly headache days

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change in monthly headache days from baseline.

  2. Mean change in migraine intensity

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change in migraine intensity from baseline.

  3. Mean change in duration of migraine attacks

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change in migraine attack duration (hours) from baseline.

  4. Proportion of attacks requiring rescue medication

    Time frame: Weeks 7-10

    Between-group comparison of the proportion of migraine attacks requiring rescue medication.

  5. Number of participants with ≥30% and ≥50% reduction in monthly migraine days

    Time frame: Weeks 7-10

    Between-group comparison of the proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days.

  6. Mean change in PROMIS-PI SF-6b

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change from baseline in PROMIS-PI SF-6b scores. The raw scores are converted to standardized T-scores (range 0-100; mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference.

  7. Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change from baseline in MSQ scores. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.

  8. Mean change in Patient Global Impression of Severity (PGI-S)

    Time frame: Weeks 7-10

    Between-group comparison of the difference in mean change from baseline in PGI-S scores. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity.

  9. Mean change in monthly migraine days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in monthly migraine days within each group.

  10. Mean change in monthly headache days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in monthly headache days within each group.

  11. Mean change in migraine intensity (6-point severity scale)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in migraine intensity within each group. Migraine intensity is assessed using a 6-point severity scale (1 = Very mild, 6 = Very severe), where higher scores indicate greater pain severity.

  12. Mean change in duration of migraine attacks

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in duration of migraine attacks (hours) within each group.

  13. Proportion of migraine attacks requiring rescue medication

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Proportion of migraine attacks requiring rescue medication within each group.

  14. Number of participants with ≥30% and ≥50% reduction in monthly migraine days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days within each group.

  15. Mean change in PROMIS-PI SF-6b

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PROMIS-PI SF-6b scores within each group. The raw scores are converted to standardized T-scores (mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference.

  16. Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PROMIS-PI SF-6b, MSQ, and PGI-S scores within each group. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.

  17. Mean change in Patient Global Impression of Severity (PGI-S)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PGI-S scores within each group. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity.

  18. Mean change in monthly migraine days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in monthly migraine days, pooled across both groups.

  19. Mean change in monthly headache days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in monthly headache days, pooled across both groups.

  20. Mean change in migraine intensity (6-point severity scale)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in migraine intensity, pooled across both groups. Migraine intensity is assessed using a 6-point severity scale (1 = Very mild, 6 = Very severe), where higher scores indicate greater pain severity."

  21. Mean change in duration of migraine attacks

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in duration of migraine attacks (hours), pooled across both groups.

  22. Proportion of migraine attacks requiring rescue medication

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Proportion of migraine attacks requiring rescue medication, pooled across both groups.

  23. Number of participants with ≥30% and ≥50% reduction in monthly migraine days

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days, pooled across both groups.

  24. Mean change in PROMIS-PI SF-6b

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PROMIS-PI SF-6b scores, pooled across both groups. The raw scores are converted to standardized T-scores (mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference.

  25. Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PROMIS-PI SF-6b, MSQ, and PGI-S scores, pooled across both groups. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.

  26. Mean change in Patient Global Impression of Severity (PGI-S)

    Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20

    Change from baseline in PGI-S scores, pooled across both groups. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity.

  27. Proportion of prescribed treatments completed

    Time frame: Throughout the 6-week treatment period

    Compliance based on device usage logs or participant-reported treatment diaries.

  28. Adverse Events / Serious Adverse Events / Device Effects

    Time frame: Through study completion (14 or 20 weeks, depending on treatment group)

    Number of treatment-related AEs, SAEs, ADEs, SADEs, and Unanticipated SADEs for the Walther System.

  29. Device Deficiencies

    Time frame: Throughout the 6-week treatment period

    Number of device deficiencies for the Walther System.

Other outcomes

  1. Device usability and user experience (combined questionnaires)

    Time frame: Throughout the 6-week treatment period

    User-reported usability, ease of use, handling, and overall experience of the device during home use, assessed using two Device Usability Questionnaires. Questions include multiple 3- or 5-point scales, 0-10 scales, and yes/no responses. Higher scores indicate better usability or greater interest where applicable.

  2. Symptom trends (Symptom Questionnaire)

    Time frame: Throughout the 6-week treatment period

    Changes in symptoms potentially related to autonomic nervous system function, assessed using the Symptom Questionnaire at Visits 1-5. The questionnaire includes multiple items with 0-6 and 0-3 ordinal scales, yes/no responses, and other response formats. Higher scores indicate more severe symptoms."

Study contacts

Contact information is provided by the study sponsor or research team.

Karl-Johan Pantzar, MSc, MSc

CONTACT

[email protected]

+46(0)739808065

Sponsors and collaborators

Lead sponsor

Abilion Medical Systems AB

Industry

Collaborators

  • Aurevia
  • Insamlingsstiftelsen för främjande av forskning avseende INMEST

Registry information

Official study title

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

Acronym: A-MI-01

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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