The trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with chronic migraine. Chronic migraine is a condition that causes moderate to severe headache. In this study, the investigators want to evaluate the freezing technique in chronic migraine. The main goal is to see how much headache relief is experienced after receiving the treatment. The investigators will also record other important information about the participants. The study is looking to recruit 12 adults with chronic migraine to take part in the study. Participants will register their headache burden in a headache diary for at least 4 weeks before receiving treatment with the freezing technique. They will continue to register headache in the headache diary during the follow-up. After this initial treatment, participants with recurring headache can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique may be viable treatment option for chronic migraine and enable us plan for further studies on this treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cryoneurolysis
St. Olavs hospital
Trondheim, Norway
Headache days - severe and moderate
Difference in change in mean monthly headache days with moderate or severe intensity
Time frame: Weeks 5 - 8 post intervention versus baseline
Safety - AE and SAE
Occurrence of treatment-emergent AE and SAE
Time frame: 8 weeks post-intervention
Headache days - any intensity
Difference in change in mean monthly headache days with any intensity
Time frame: Weeks 5 - 8 post intervention versus baseline
Migraine days
Difference in change in mean monthly migraine days
Time frame: Weeks 5 - 8 post intervention versus baseline
Responders 30%
Number of 30% responders
Time frame: Weeks 5 - 8 post-intervention
Responders 50%
Number of 50% responders
Time frame: Weeks 5 - 8 post-intervention
Headache Intensity
Difference in the mean monthly headache intensity with a 11 point VAS scale as registered in headache diary
Time frame: Weeks 5 - 8 post intervention versus baseline
Medication consumption
Difference in mean monthly days with acute medication consumption as registered in headache diary
Time frame: Weeks 5 - 8 post intervention versus baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.