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Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine | Clinical Trials | Clareo Health

COMPLETEDNA

Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

NCT03400059•Chordate Medical

View on ClinicalTrials.gov

Summary

The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment will be examined in patients diagnosed with chronic migraine. The medical device system will be applied in 6 treatments at weekly intervals. The study will examine the effects on monthly headache days with moderate to severe intensity.

Detailed Description

This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period. The study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
•2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
•3. Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month for more than 3 months before screening including at least 8 migraine days) according to the IHS classification (International Classification of Headache Disorders \[ICHD\]-III beta);
•4. Migraine onset before the age of 60 years;
•5. Reported history of migraine for at least 1 year before screening;
•6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
•7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
•8. Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate \<1% per year when used consistently and correctly) during the study.

Exclusion Criteria

•1. Unable to distinguish between migraine headaches and other headache types;
•2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
•3. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
•4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
•5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;
•6. Fitted with a pacemaker/defibrillator;
•7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
•8. Ongoing upper respiratory infection or malignancy in the nasal cavity;
•9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
•10. Head injury or open wound that contraindicates use of the Chordate Headband;
+6 more criteria

Locations (10)

Terveystalo Ruoholahti

Helsinki, Finland

Helsingin päänsärkykeskus / Aava Itäkeskus

Helsinki, Finland

Terveystalo Tampere

Tampere, Finland

Suomen Terveystalo Turku

Turku, Finland

Lewis Neurologie

Stuttgart, Baden-Wurttemberg, Germany

Neurologie- & Kopfschmerzzentrum

München, Bavaria, Germany

Klinikum Großhadern / Neurologische Klinik der Universität München

München, Bavaria, Germany

Migräne-Klinik Königstein

Königstein im Taunus, Hesse, Germany

Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie

Rostock, Mecklenburg-Vorpommern, Germany

CTC North am Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Key Dates

Start Date

March 22, 2018

Primary Completion Date

August 1, 2022

Completion Date

August 1, 2022

Last Updated

January 6, 2025

Enrollment

144

ACTUAL participants

Conditions

Chronic Migraine

Interventions

Chordate System S211 in treatment mode

DEVICE

Chordate System S211 in placebo mode

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine

Inclusion Criteria

Exclusion Criteria

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