Back to resultsSphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
Primary Purpose
Headache, Stroke, Ischemic Stroke
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liquid Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring Post-Stroke Headache, Sphenopalatine Ganglion (SPG) block
Eligibility Criteria
Inclusion Criteria:
- 18 years or older;
- hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician;
- 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:
- Previous treatment with SPG Block for post-stroke headache
- history of prophylactic medication use for headache or migraine;
- pregnant at time of stroke
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Liquid Lidocaine
Sham Placebo
Arm Description
The investigational treatment is 1.5 mL of aqueous 2% lidocaine.
The placebo arm is 1.5mL of aqueous of saline.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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."
Adverse effect
Bitter taste, nose bleeding, throat discomfort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05365880
Brief Title
Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
Official Title
Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
March 22, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Stroke, Ischemic Stroke
Keywords
Post-Stroke Headache, Sphenopalatine Ganglion (SPG) block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liquid Lidocaine
Arm Type
Experimental
Arm Description
The investigational treatment is 1.5 mL of aqueous 2% lidocaine.
Arm Title
Sham Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo arm is 1.5mL of aqueous of saline.
Intervention Type
Drug
Intervention Name(s)
Liquid Lidocaine
Intervention Description
The investigational treatment is 2 mL of aqueous 2% lidocaine.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The active placebo comparator will be provided to participant.
Primary Outcome Measure Information:
Title
Change in Number of Migraine Headaches During Treatment Phase
Description
Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The quantitative scale ranges from 0 to 10, with 0 meaning "no headache at all" and 10 meaning "the worst possible headache."
Time Frame
90 days
Title
Adverse effect
Description
Bitter taste, nose bleeding, throat discomfort
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older;
hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician;
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:
Previous treatment with SPG Block for post-stroke headache
history of prophylactic medication use for headache or migraine;
pregnant at time of stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka-Ho Wong
Phone
8015857575
Email
ka-ho.wong@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Seniha Ozudogru, MD
Phone
8015857575
Email
seniha.ozudogru@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam H de Havenon, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam H de Havenon, MD, MSCI
Phone
801-585-7575
Email
adam.dehavenon@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Ka-Ho Wong, MBA
Phone
8015857575
Email
ka-ho.wong@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30054011
Citation
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.
Results Reference
result
PubMed Identifier
30152015
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 27.
Results Reference
result
PubMed Identifier
29285576
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.
Results Reference
result
PubMed Identifier
30877613
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.
Results Reference
result
PubMed Identifier
26926875
Citation
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.
Results Reference
result
PubMed Identifier
31694924
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.
Results Reference
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PubMed Identifier
32583883
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 Cerebral Ischemic Outcome in Mice. Ann Neurol. 2020 Oct;88(4):771-784. doi: 10.1002/ana.25831. Epub 2020 Aug 7.
Results Reference
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PubMed Identifier
24127913
Citation
Levin M. Opioids in headache. Headache. 2014 Jan;54(1):12-21. doi: 10.1111/head.12266.
Results Reference
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PubMed Identifier
25338927
Citation
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.
Results Reference
result
PubMed Identifier
8656545
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.
Results Reference
result
Learn more about this trial
Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache
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