"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine

The study is an an open-label, non-con trolled, single-arm and single-center phase II study, at the outpatient clinic of the Department of Neurology and Clinical neurophysiology at St. Olavs Hospital, Trondheim, Norway. The study was originally also planned at the Mayo Clinic, Scottsdale, AZ, USA, but because the study there had not been started before the COVID-19 pandemic, the study was performed only in Trondheim. Potential study participants should be identified among the regular outpatients at the Department of Neurology at St. Olavs hospital. Potential participants should recceive an email with the informed consent form, which should be signed at the screening visit where a detailed medical history and medical examination should be per formed. Patients should complete a paper head ache diary, recording pain intensity and duration, concomitant migraine symptoms (nausea, vomiting, phono- and photophobia), acute medication (type, number of doses) and work absence (yes/no/not relevant). Also, they should record any adverse events. After 7-14 days, they should receive a telephone call from a nurse asking about adverse events and concom itant medication and reminding them to maintain the daily diary. After a baseline period of at least 28 days, diaries should be reviewed at a treatment visit, and each participant should receive injections according to the described procedure. Women of child bearing potential should have a negative pregnancy test before the injections. The duration of the injection procedure should be measure with a stopwatch and immediately after the injections, the patient should be asked to record on a VAS scale (0-10) the level of pain of the procedure and the investigator recorded the degree of bleeding (no, mild, moderate, marked) and any other injection-related adverse events (AEs). Patients should then be asked were asked to keep a headache diary for another 12 weeks or more, before the end of the study visit. During this period, they should receive a call from the study nurse at weeks 2 and 9, reminding to keep the headache diary, and asking about AEs and concomitant medication. They should be also asked whether they had noticed any change in their ability to make forehead wrinkles (no, little, moderate, marked, full paralysis)