Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

NCT ID: NCT04353505

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2023-06-30

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.

Conditions

Chronic Migraine; Cluster Headache; Trigeminal Neuralgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-Arterial Delivery of Ketorolac and Dexamethasone

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Intra-arterial delivery of Ketorolac in the internal maxillary artery, once

Dexamethasone

Intervention Type: DRUG

Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.

Interventions

Ketorolac

Intra-arterial delivery of Ketorolac in the internal maxillary artery, once

Intervention Type: DRUG

Dexamethasone

Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athos Patsalides, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

WCMC

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

19-11021096

Identifier Type: -

Identifier Source: org_study_id