Migraine Disorders
Conditions
Keywords
Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block
Brief summary
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.
Interventions
DRUGBotulinum Toxin Type A
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Informed and written consent * Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria * Failed at least 3 oral migraine prophylactic treatments * Duration of migraine at least 1 year before inclusion * Start of migraine before participant turned 50 years * Participant can make a distinction between migraine and other types of headache
Exclusion criteria
* If the criteria for medication-overuse headache (MOH) is fulfilled * Heart or lung disease * Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection * Psychiatric illness that hinders participation in the study * Known pregnancy or breast feeding * Inadequate use of contraceptives * Overuse or abuse of opioids * Abuse of medications, narcotics or alcohol * Anomalies which hinder or impede the used method of injection * Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication * Treatment with medication that can interact with botulinum toxin type A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events and number of participants with adverse events | For the follow-up period of 3 months | 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. |
| Number of headache days with moderate or severe intensity | 5-8 weeks | measured from week 5 to week 8, in total during 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of reponders | 12 weeks | 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) |
| Days with moderate or severe headache per 4 weeks | 12 weeks | week 1-4, week 5-8, week 9-12 |
| Days without headache per 4 weeks | 12 weeks | week 1-4, week 5-8, week 9-12 |
| Hours with headache of moderate or severe headache per 4 weeks | 12 weeks | week 1-4, week 5-8, week 9-12 |
Countries
Norway
Outcome results
None listed