Sphenopalatine Ganglion Block for Headache After Concussion

A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion

This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.

Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).

Study Overview

• Status: Terminated
• Conditions: Headache; Concussion
• Intervention / Treatment: Combination product: Lidocaine in SphenoCath device; Combination product: Saline Solution in SphenoCath device

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with a concussion and are greater than 14 days from the date of their injury.
• Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.

Exclusion Criteria:

• Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
• Frequent epistaxis (i.e. more than one nose bleed per month),
• Bleeding disorders
• History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
• Pregnant
• Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine in SphenoCath device; One treatment will be given.	Combination product: Lidocaine in SphenoCath device; Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.
Placebo Comparator: Saline Solution in SphenoCath device; One treatment will be given.	Combination product: Saline Solution in SphenoCath device; Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Headache Severity Score	Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."	48 hours pre-SPG to 48 hours after SPG block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC)	A rating scale of global improvement which participants use a seven-point scale ("1" = very much improved, "4" = no change, "7" very much worse). Participants will rate their change at two hours and 24 hours following the SPG block procedure.	2, 24 hours after SPG block
Mean Change in the Number of Headache Occurrences	The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.	1 week before SPG block, up to 1 week post SPG block
Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block	The number of headache episodes prior to the SPG block to after the procedure.	48 hours pre SPG to 48 hours post block
Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block	The number of headache episodes over the one week prior to the SPG block to one week after the procedure.	1 week before SPG block up to 1 week post SPG block
Mean Change in Headache Hours Per Day	The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.	1 week before SPG block, up to 1 week post SPG block
Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block		48 hours pre SPG up to 48 hours post SPG
Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block		1 week before SPG block to 1 week post SPG block
Mean Change in the Number of Days With Headache		1 week before SPG block, up to 1 week post SPG
Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.		1 week before SPG block up to 1 week post SPG
Mean Change in As-needed Headache Treatment Uses	Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.	1 week before SPG block to 1 week post SPG block
Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG	Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.	48 hours before SPG block to 48 hours post SPG block
Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block	Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.	1 week before SPG block up to 1 week post SPG block

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Michael Popovich, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: headaches; sphenopalatine ganglion block; Concussions
• Additional Relevant MeSH Terms: Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache; Ganglion Cysts; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: HUM00185200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon request, I will share de-identified participant demographic information, outcome data, study protocol, statistical analysis plan, and informed consent form.
• IPD Sharing Time Frame: The data will be made available within 6 months of the study's conclusion, and will remain available for at least 5 years thereafter.
• IPD Sharing Access Criteria: Data will be made available if requested, pending a data use agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No