A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine
Study Details
Study Description
Brief Summary
An open pilot study, non-controlled, single center investigation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: KOS treatment 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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 calcitonin gene-related peptide (CGRP), [Baseline to 12 weeks]
Change in calcitonin gene-related peptide (CGRP) in blood plasma
- Mean change in pituitary adenylate cyclase-activating peptide (PACAP) [Baseline to 12 weeks]
Change in pituitary adenylate cyclase-activating peptide (PACAP) in blood plasma
- Mean change in amylin [Baseline to 12 weeks]
Change in amylin in blood plasma.
- 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
- 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 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)
- 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 Mild Moderate Severe
- Mean change in headache days [week 6-12]
Change in headache days with moderate to severe intensity from eDiary
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;
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Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
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Migraine onset before the age of 50 years;
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Reported history of migraine for at least 1 year before screening;
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Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;
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Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;
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Failed at least 3 different preventive medications and 3 months of treatment with a monoclonal antibody targeting the CGRP pathway;
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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:
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Unable to distinguish between migraine and other headache types;
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Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;
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Ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;
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Treatment with non-invasive neuromodulation technique in the past, such as for example nVNS or sTMS < 1 month before screening visit;
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Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;
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History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid rhinorrhea;
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Fitted with a pacemaker/defibrillator;
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Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);
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Ongoing upper respiratory infection or malignancy in the nasal cavity;
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History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;
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Head injury or open wound that contraindicates use of the Chordate Headband;
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Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;
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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;
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Pregnant and lactating women;
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Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
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Previous participation in this study;
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Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals;
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Patients who has not been fully vaccinated for SARS-CoV-2;
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Use of opioid containing analgesics on more than 4 days per month.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chordate Medical
Investigators
- Principal Investigator: Jan Hoffmann, MD, PhD, Wellcome Foundation Building, Denmark Hill Campus King's College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PM009