What is the purpose of the study?

To assess the usefulness of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after 6 weeks of treatment.

Who can take part?

People who are:

• Aged between 18 and 70 years
• Diagnosed as suffering from chronic migraine with or without aura
• Greater then 15 headache days per month including at least 8 migraine days for more than 3 months before screening)
  Age of onset of migraines prior to 50 years of age
• Failed at least 3 different preventive medications and 3 months of treatment with a monoclonal antibody targeting the CGRP pathway.

What will the study involve?

If you agree to take part, your participation in the study will last approximately 22 weeks and will include 9-10 study visits. Each visit will take approximately an hour.

• You will be asked to complete an electronic diary
• You will be asked to complete the study questionnaires
• You will undergo treatment with the CHORDATE System. The investigational medical device system is the Chordate System S220, which is used to stimulate human tissue inside the nasal cavities by means of kinetic oscillations at low frequencies. The mechanism of action is believed to be that the mechanical stimulation has a rebalancing effect such that migraine attacks become less frequent and less severe.

How to take part

Full details of the trial, and your involvement, will be provided by the study team and also explained during your first visit or telephone call.
You are encouraged to ask as many questions, and take as much time as you need, in order to make an informed decision about whether to take part.

If you would like to take part in the study or if you have any questions, please contact headache-research@kcl.ac.uk.