NCT04650282

Sphenopalatine Ganglion Block for Headache After Concussion

A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores. Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).

Conditions

• Concussion
• Headache

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lidocaine in SphenoCath device	Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.
COMBINATION_PRODUCT	Saline Solution in SphenoCath device	Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-04-01
• Completion: 2021-04-06
• First posted: 2020-12-02
• Last updated: 2022-09-14
• Results posted: 2022-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study