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

NCT ID: NCT03400059

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-22
• Study Completion Date: 2022-08-01

Brief 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.

Conditions

Chronic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active Treatment

Group Type: EXPERIMENTAL

Chordate System S211 in treatment mode

Intervention Type: DEVICE

Chordate System S211 in treatment mode

Sham Treatment

Group Type: SHAM_COMPARATOR

Chordate System S211 in placebo mode

Intervention Type: DEVICE

Chordate System S211 in placebo mode

Interventions

Chordate System S211 in treatment mode

Chordate System S211 in treatment mode

Intervention Type: DEVICE

Chordate System S211 in placebo mode

Chordate System S211 in placebo mode

Intervention Type: DEVICE

Eligibility Criteria

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;

11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;

12. Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;

13. Pregnant and lactating women;

14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;

15. Previous participation in this study;

16. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vinnova

OTHER_GOV

Sponsor Role: collaborator

FGK Clinical Research GmbH

INDUSTRY

Sponsor Role: collaborator

Chordate Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arne May, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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

Countries

Finland; Germany

References

Hoffmann J, Kaube H, Rimmele F, Jurgens TP, Nissila M, Gaul C, Kallela M, Keski-Santti P, Sumelahti ML, Straube A, Lewis D, Hoffmann V, Wirtz L, Rempel A, Bohm O, May A. Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial. Neurology. 2025 Feb 11;104(3):e210220. doi: 10.1212/WNL.0000000000210220. Epub 2025 Jan 9.

Reference Type: DERIVED

PMID: 39787477 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PM007

Identifier Type: -

Identifier Source: org_study_id