A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine

Not Applicable

Recruiting

• Conditions: Chronic Migraine
• Interventions: Device: KOS (Intranasal kinetic oscillation stimulation)

• Registration Number: NCT05273151
• Lead Sponsor: Chordate Medical

Brief Summary

An open pilot study, non-controlled, single center investigation.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-10
• Study Start: 2023-12-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-12-30
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KOS treatment	KOS (Intranasal kinetic oscillation stimulation)	Treatment with intranasal kinetic oscillation stimulation (KOS)

Primary Outcome Measures

Name	Time	Method
Mean change in headache days	baseline to 6 weeks	Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary

Secondary Outcome Measures

Name	Time	Method
Mean change in Hospital Anxiety and Depression Scale (HADS)	baseline to 12 weeks	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)
Number of patients who decrease use of abortive medication	baseline to 12 weeks	Intake of abortive medications are registred in eDiary and will be calculated on patient level
Mean change in headache days	week 6-12	Change in headache days with moderate to severe intensity from eDiary
Incidence of adverse events (AEs) and adverse device effects (ADEs)	Baseline to 12 weeks	All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with the Chordate System 220
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)	Baseline to 12 weeks	Migraine days is collected in an eDiary.
Number of patients who are responders	baseline to 12 weeks	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
Mean change in Headache Impact Test (HIT-6)	baseline to 12 weeks	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
Mean change in Subject global severity	baseline to 12 weeks	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

Trial Locations

Locations (4)

Kopfschmerzzentrum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsklinik für Neurologie Inselspital; 🇨🇭 Bern, Switzerland

Hull Royal Infirmary, Hull University Teaching Hospital; 🇬🇧 Hull, United Kingdom

Wolfson Centre for Age-Related Diseases Institute of Psychiatry, Psychology and Neuroscience Wellcome Foundation Building, Denmark Hill Campus King's College; 🇬🇧 London, United Kingdom