Sphenopalatine Ganglion Block for Headache After Concussion

NCT ID: NCT04650282

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2021-04-06

Brief Summary

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).

Conditions

Concussion; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine in SphenoCath device

One treatment will be given.

Group Type: EXPERIMENTAL

Lidocaine in SphenoCath device

Intervention Type: COMBINATION_PRODUCT

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.

Saline Solution in SphenoCath device

One treatment will be given.

Group Type: PLACEBO_COMPARATOR

Saline Solution in SphenoCath device

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Michael Popovich

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Popovich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00185200

Identifier Type: -

Identifier Source: org_study_id