Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Stroke Clinical Trial

Official title:

Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365880
• Other study ID #: 138103
• Status: Recruiting
• Phase: Phase 2
• Start date: March 23, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: University of Utah
• Contact: Ka-Ho Wong
• Phone: 8015857575
• Email: ka-ho.wong[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.

Description:

The purpose of this study is to determine if sphenopalatine ganglion (SPG) block is a safe and effective treatment for acute post-stroke headache. Current literature lacks randomized controlled studies regarding the efficacy of different treatment modalities for acute post-stroke headache; additionally, there are no evidence-based guidelines for the treatment of acute post-stroke headache. Sphenopalatine ganglion block is a non-invasive procedure where an anesthetic agent is injected into the nares, reaching the SPG to relieve pain and autonomic features. This treatment has been effective in a variety of headache types but to our knowledge has not been studied in acute post-stroke headache.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years or older;

2. hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician;

3. meets at least one of the following International Classification of Headache Disorder-3 (ICHD-3) criteria: 6.1.1.1 (Acute Headache Attributed to Ischemic Stroke), 6.2.1 (Headache attributed to non-traumatic intracerebral hemorrhage), 6.2.2 (Acute headache attributed to non-traumatic subarachnoid hemorrhage); received at least one medication for headache during hospitalization.

Exclusion Criteria:

1. Previous treatment with SPG Block for post-stroke headache

2. history of prophylactic medication use for headache or migraine;

3. pregnant at time of stroke

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Liquid Lidocaine
The investigational treatment is 2 mL of aqueous 2% lidocaine.
• Placebo
The active placebo comparator will be provided to participant.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (10)

Androulakis XM, Krebs KA, Ashkenazi A. Hemicrania continua may respond to repetitive sphenopalatine ganglion block: A case report. Headache. 2016 Mar;56(3):573-9. doi: 10.1111/head.12783. Epub 2016 Mar 1. — View Citation

Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360(®) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub — View Citation

Delpont B, Blanc C, Osseby GV, Hervieu-Bègue M, Giroud M, Béjot Y. Pain after stroke: A review. Rev Neurol (Paris). 2018 Dec;174(10):671-674. doi: 10.1016/j.neurol.2017.11.011. Epub 2018 Jul 24. Review. — View Citation

Harriott AM, Karakaya F, Ayata C. Headache after ischemic stroke: A systematic review and meta-analysis. Neurology. 2020 Jan 7;94(1):e75-e86. doi: 10.1212/WNL.0000000000008591. Epub 2019 Nov 6. — View Citation

Ho KWD, Przkora R, Kumar S. Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review. J Headache Pain. 2017 Dec 28;18(1):118. doi: 10.1186/s10194-017-0826-y. Review. — View Citation

Lai J, Harrison RA, Plecash A, Field TS. A Narrative Review of Persistent Post-Stroke Headache - A New Entry in the International Classification of Headache Disorders, 3rd Edition. Headache. 2018 Oct;58(9):1442-1453. doi: 10.1111/head.13382. Epub 2018 Aug — View Citation

Levin M. Opioids in headache. Headache. 2014 Jan;54(1):12-21. doi: 10.1111/head.12266. Review. — View Citation

Maizels M, Scott B, Cohen W, Chen W. Intranasal lidocaine for treatment of migraine: a randomized, double-blind, controlled trial. JAMA. 1996 Jul 24-31;276(4):319-21. — View Citation

Mulder IA, Li M, de Vries T, Qin T, Yanagisawa T, Sugimoto K, van den Bogaerdt A, Danser AHJ, Wermer MJH, van den Maagdenberg AMJM, MaassenVanDenBrink A, Ferrari MD, Ayata C. Anti-migraine Calcitonin Gene-Related Peptide Receptor Antagonists Worsen Cerebr — View Citation

Rosso C, Felisati G, Bulfamante A, Pipolo C. Cluster headache: crosspoint between otologists and neurologists-treatment of the sphenopalatine ganglion and systematic review. Neurol Sci. 2019 May;40(Suppl 1):137-146. doi: 10.1007/s10072-019-03796-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Migraine Headaches During Treatment Phase	Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary	90 days
Secondary	Numeric Pain Rating Scale	The quantitative scale ranges from 0 to 10, with 0 meaning "no headache at all" and 10 meaning "the worst possible headache."	90 days
Secondary	Adverse effect	Bitter taste, nose bleeding, throat discomfort	90 days