An interventional study of KOS (Intranasal kinetic oscillation stimulation) in Chronic Migraine, sponsored by Chordate Medical. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Chordate Medical · Not applicable, Interventional, and Prevention
An open pilot study, non-controlled, single center investigation.
An open pilot study, non-controlled, single center investigation. The study consists of a 4-week screening period, a 6-week treatment period, and a 12 week follow-up period.
Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments.
Subjects who completed the screening period and continue to meet the eligibility criteria after review of diary entries by the investigator will receive treatment. The subjects will receive 6 treatments with the Chordate System S220 at weekly intervals at the site (Day 0 to 35; treatment Visit [V] 1 to 6) and continue to maintain a daily diary.
After completion of the 6-week study treatment period (V1 to V6), subjects will be treated monthly and followed up for another 12 weeks. The final visit will be performed on Day 125, 12 weeks after the last study treatment. During the 12-week follow-up, the subjects will continue to complete a daily diary.
Chordate Medical is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Treatment with intranasal kinetic oscillation stimulation (KOS)
Device: KOS (Intranasal kinetic oscillation stimulation)
Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.
Mean change in headache days
Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary
Time frame: baseline to 6 weeks
Mean change in Migraine days Mean change of migraine days, responder rate, use of abortive medication, health-related quality of life and disability, and patient's global impression of severity 12 weeks (90 days)
Migraine days is collected in an eDiary.
Time frame: Baseline to 12 weeks
Incidence of adverse events (AEs) and adverse device effects (ADEs)
All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with the Chordate System 220
Time frame: Baseline to 12 weeks
Number of patients who are responders
Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days). A respondes is a patient who has decrease of headaches/migraine days whilst a non responder had no or the same number of headache/migraine days
Time frame: baseline to 12 weeks
Number of patients who decrease use of abortive medication
Intake of abortive medications are registred in eDiary and will be calculated on patient level
Time frame: baseline to 12 weeks
Mean change in Hospital Anxiety and Depression Scale (HADS)
HADS is a scale with 7 questions related to anxiety and 7 questions related to depression Anxiety can have 0-21 points (lower score means no anxiety) and Depression 0-21 points (higher score means no depression)
Time frame: baseline to 12 weeks
Mean change in Headache Impact Test (HIT-6)
HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score means less problems
Time frame: baseline to 12 weeks
Mean change in Subject global severity
Patient Global severity is a scale with four (4) scores, where normal (0) is the lowest and show no problems whilst severe (3) is the worst score 0=Normal 1. Mild 2. Moderate 3. Severe
Time frame: baseline to 12 weeks
Mean change in headache days
Change in headache days with moderate to severe intensity from eDiary
Time frame: week 6-12
Plan to share: No — Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Chordate Medical