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

CompletedNot applicableNCT03400059
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Interventions
  • Device: Chordate System S211 in treatment mode
  • Device: Chordate System S211 in placebo mode
Sponsor
Chordate Medical
Collaborators
Vinnova; FGK Clinical Research GmbH
Start date
2018-03-22
Primary completion
2022-08-01
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Finland, Germany
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 op…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03400059