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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05365880
Other study ID # 138103
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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