Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
NCT ID: NCT05365880
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-03-23
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Liquid Lidocaine
The investigational treatment is 1.5 mL of aqueous 2% lidocaine.
Liquid Lidocaine
The investigational treatment is 2 mL of aqueous 2% lidocaine.
Sham Placebo
The placebo arm is 1.5mL of aqueous of saline.
Placebo
The active placebo comparator will be provided to participant.
Interventions
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Liquid Lidocaine
The investigational treatment is 2 mL of aqueous 2% lidocaine.
Placebo
The active placebo comparator will be provided to participant.
Eligibility Criteria
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Inclusion Criteria
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
2. history of prophylactic medication use for headache or migraine;
3. pregnant at time of stroke
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Principal Investigators
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Adam H de Havenon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Delpont B, Blanc C, Osseby GV, Hervieu-Begue M, Giroud M, Bejot 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.
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 27.
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.
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.
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.
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.
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 Cerebral Ischemic Outcome in Mice. Ann Neurol. 2020 Oct;88(4):771-784. doi: 10.1002/ana.25831. Epub 2020 Aug 7.
Levin M. Opioids in headache. Headache. 2014 Jan;54(1):12-21. doi: 10.1111/head.12266.
Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.
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.
Other Identifiers
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138103
Identifier Type: -
Identifier Source: org_study_id
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