Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine (A-MI-01)

December 10, 2025 updated by: Abilion Medical Systems AB

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Karl-Johan Pantzar, MSc, MSc
  • Phone Number: +46(0)739808065
  • Email: kj@abilion.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • Walther System
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.
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.
Other Names:
  • Walther System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Weeks 7-10
Mean change in migraine intensity
Time Frame: Weeks 7-10
Between-group comparison of the difference in mean change in migraine intensity from baseline.
Weeks 7-10
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.
Weeks 7-10
Proportion of attacks requiring rescue medication
Time Frame: Weeks 7-10
Between-group comparison of the proportion of migraine attacks requiring rescue medication.
Weeks 7-10
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.
Weeks 7-10
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.
Weeks 7-10
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.
Weeks 7-10
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.
Weeks 7-10
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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 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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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."
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
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.
Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Proportion of prescribed treatments completed
Time Frame: Throughout the 6-week treatment period
Compliance based on device usage logs or participant-reported treatment diaries.
Throughout the 6-week treatment period
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.
Through study completion (14 or 20 weeks, depending on treatment group)
Device Deficiencies
Time Frame: Throughout the 6-week treatment period
Number of device deficiencies for the Walther System.
Throughout the 6-week treatment period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Throughout the 6-week treatment period
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."
Throughout the 6-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abilion Medical Systems AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Insamlingsstiftelsen för främjande av forskning avseende INMEST
Aurevia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan-Erik Juto, PhD, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-MI-01
  • CIV-25-05-052936 (Registry Identifier: Swedish Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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