Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
- Conditions
- Chronic MigraineCluster HeadacheTrigeminal Neuralgia
- Interventions
- Registration Number
- NCT04353505
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intra-arterial (IA) delivery of Dexamethasone and Ketorolac into the arteries supplying the sphenopalatine ganglion (SPG) - a collection of neurons that plays an important role in headache disorders - in patients with refractory migraine, cluster headache and trigeminal neuralgia. All patients must fail standard treatments prior to enrollment in the trial.
- Detailed Description
The investigators propose an outpatient, minimally invasive method to deliver Dexamethasone and Ketorolac to the SPG via the intra-arterial route. A microcatheter will be advanced via the radial (preferably) or the femoral artery (in case the radial approach is not feasible) using fluoroscopic guidance and standard interventional techniques, into the distal internal maxillary artery. This artery is a branch of the external carotid artery and supplies the territory of the sphenopalatine ganglion. The microcatheter will be advanced to the ostium of the distal small branches that supply the SPG (i.e. small arteries feeding the vasa nervosum). Once the microcatheter is in a good position, 15 mg Dexamethasone Sodium Phosphate and 15 mg of Ketorolac Tromethamine will be infused over 30 minutes.
The procedure will be performed with local anesthetic at the arterial puncture site. Conscious sedation will be used for anxious participants. After the procedure, the participant will be observed for 5 hours in ICU setting and then discharged to home.
The procedure will be performed unilaterally for participants with cluster headache and trigeminal neuralgia. The procedure could be performed bilaterally for participants with migraine.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Established diagnosis of one of the three following headache or facial pain disorders as defined by the ICHD-329 [chronic migraine, cluster headache, trigeminal neuralgia] and failure to respond to two or more preventive therapies
A. Chronic migraine
Failure to respond to two or more preventive therapies including Onabotulinumtoxin A, erenumab, fremanezumab, galcanezumab, topiramate, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, amitriptyline, nortriptyline, venlafaxine, duloxetine.
This will include status migrainosus.
B. Cluster headache
Failure to respond to Verapamil, AND one other preventive treatment including Prednisone, Dexamethasone, galcanezumab, lithium, valproic acid, topiramate, external vagus nerve stimulation
C. Trigeminal neuralgia
Failure to respond to two or more preventive therapies, including: Oxcarbazepine or carbamazepine, and One of the following: gabapentin, pregabalin, baclofen, lamotrigine, phenytoin
- Patients with malignant neoplasm of the pterygopalatine fossa
- Pregnancy, lactation
- Severe allergic reaction to Dexamethasone
- Severe allergic reaction to NSAID
- Renal failure
- Active systemic infection or fever
- Known cerebral vascular disease
- Drug or alcohol abuse
- Opioid dependency (stable doses ok)
- Triptans within 48 hours from the procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intra-Arterial Delivery of Ketorolac and Dexamethasone Ketorolac - Intra-Arterial Delivery of Ketorolac and Dexamethasone Dexamethasone -
- Primary Outcome Measures
Name Time Method Number of Procedure-Related Adverse Events 2 weeks post procedure
- Secondary Outcome Measures
Name Time Method Change in Number of Days of Headache in Subjects with Chronic Migraine 1 week, 2 weeks, 4 weeks, 6 weeks Proportion of Chronic Migraine Patients that achieve at least 50% reduction in days of headache frequency 1 week, 2 weeks, 4 weeks, 6 weeks Proportion of patients with Cluster Headache that achieve 50% reduction in median number of attacks per day 1 week, 2 weeks, 4 weeks, 6 weeks Change in number of days of facial pain for subjects with trigeminal neuralgia 1 week, 2 weeks, 4 weeks, 6 weeks Proportion of patients with trigeminal neuralgia that achieve at least 50% reduction in days of facial pain frequency 1 week, 2 weeks, 4 weeks, 6 weeks
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States