Clinical trial NCT05365880: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Headache
Stroke
Ischemic Stroke
Keywords: Post-Stroke Headache
Sphenopalatine Ganglion (SPG) block
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Migraine Headaches During Treatment Phase
timeFrame: 90 days
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 90 days
measure: Adverse effect
timeFrame: 90 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Adam H de Havenon, MD
role: PRINCIPAL_INVESTIGATOR
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