Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect. The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion. The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail. The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim, Norway
Number of adverse events and number of participants with adverse events
Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
Time frame: For the follow-up period of 3 months
Number of headache days with moderate or severe intensity
measured from week 5 to week 8, in total during 4 weeks
Time frame: 5-8 weeks
Number of reponders
response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
Time frame: 12 weeks
Days with moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12
Time frame: 12 weeks
Days without headache per 4 weeks
week 1-4, week 5-8, week 9-12
Time frame: 12 weeks
Hours with headache of moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12
Time frame: 12 weeks
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