Study Summary
This trial will test whether SPG block can relieve post-stroke headache.
Eligible Conditions
- Stroke
- Headache
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 90 days
90 days
Adverse effect
Change in Number of Migraine Headaches During Treatment Phase
Change of Numeric Pain Rating Scale from admission to discharge
Numeric Pain Rating Scale
Headache
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Liquid Lidocaine
1 of 2
Sham Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
20 Total Participants · 2 Treatment Groups
Primary Treatment: Liquid Lidocaine · Has Placebo Group · Phase 2
Liquid Lidocaine
Drug
Experimental Group · 1 Intervention: Liquid Lidocaine · Intervention Types: DrugSham Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
Who is running the clinical trial?
University of UtahLead Sponsor
1,002 Previous Clinical Trials
1,785,034 Total Patients Enrolled
17 Trials studying Stroke
2,388 Patients Enrolled for Stroke
Adam H de Havenon, MDPrincipal InvestigatorUniversity of Utah
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old.\n
You have a diagnosis of acute ischemic or hemorrhagic stroke.
You have had a headache for at least 3 days, and it is due to a stroke, intracerebral hemorrhage, or subarachnoid hemorrhage.
References
- Ho, Kwo Wei David, Rene Przkora, and Sanjeev Kumar. 2017. “Sphenopalatine Ganglion: Block, Radiofrequency Ablation and Neurostimulation - a Systematic Review”. The Journal of Headache and Pain. Springer Science and Business Media LLC. doi:10.1186/s10194-017-0826-y.
- Cady, Roger, Joel Saper, Kent Dexter, and Heather R. Manley. 2014. “A Double‐blind, Placebo‐controlled Study of Repetitive Transnasal Sphenopalatine Ganglion Blockade Withtx360®as Acute Treatment for Chronic Migraine”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12458.
- Lai, Joshua, Rebecca A. Harrison, Alyson Plecash, and Thalia S. Field. 2018. “A Narrative Review of Persistent Post-stroke Headache - A New Entry in the International Classification of Headache Disorders, 3rd Edition”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.13382.
- Michelle Androulakis, X., Kaitlin A. Krebs, and Avi Ashkenazi. 2016. “Hemicrania Continua May Respond to Repetitive Sphenopalatine Ganglion Block: A Case Report”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12783.
- Delpont, B., C. Blanc, G.V. Osseby, M. Hervieu-Bègue, M. Giroud, and Y. Béjot. 2018. “Pain After Stroke: A Review”. Revue Neurologique. Elsevier BV. doi:10.1016/j.neurol.2017.11.011.
- Harriott, Andrea M., Fahri Karakaya, and Cenk Ayata. 2019. “Headache After Ischemic Stroke”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000008591.
- Rosso, Cecilia, Giovanni Felisati, Antonio Bulfamante, and Carlotta Pipolo. 2019. “Cluster Headache: Crosspoint Between Otologists and Neurologists—treatment of the Sphenopalatine Ganglion and Systematic Review”. Neurological Sciences. Springer Science and Business Media LLC. doi:10.1007/s10072-019-03796-5.
- Mulder, Inge A., Mei Li, Tessa Vries, Tao Qin, Takeshi Yanagisawa, Kazutaka Sugimoto, Antoon Bogaerdt, et al.. 2020. “Anti‐migraine Calcitonin Gene–related Peptide Receptor Antagonists Worsen Cerebral Ischemic Outcome in Mice”. Annals of Neurology. Wiley. doi:10.1002/ana.25831.
- Levin, Morris. 2014. “Opioids in Headache”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12266.
- Diamond, M. L.. 1996. “Intranasal Lidocaine for Treatment of Migraine”. JAMA: The Journal of the American Medical Association. American Medical Association (AMA). doi:10.1001/jama.276.19.1553c.
- 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.
- 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.
- Levin M. Opioids in headache. Headache. 2014 Jan;54(1):12-21. doi: 10.1111/head.12266.
- 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.
- Adam de Havenon 2022. "Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05365880.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments