Sphenopalatine Ganglion Block for Headache After Concussion

NCT04650282 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: HUM00185200
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

Concussions; headaches; sphenopalatine ganglion block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Patient Global Impression of Change (PGIC)

  2, 24 hours after SPG block

• Mean Change in the Number of Headache Occurrences

  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

  48 hours pre SPG to 48 hours post block

• Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block

  1 week before SPG block up to 1 week post SPG block

• Mean Change in Headache Hours Per Day

  1 week before SPG block, up to 1 week post SPG block

Study Arms (2)

Lidocaine in SphenoCath device

EXPERIMENTAL

One treatment will be given.

Combination Product: Lidocaine in SphenoCath device

Saline Solution in SphenoCath device

PLACEBO COMPARATOR

One treatment will be given.

Combination Product: Saline Solution in SphenoCath device

Interventions

Lidocaine in SphenoCath device 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.

Lidocaine in SphenoCath device

Saline Solution in SphenoCath device 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.

Saline Solution in SphenoCath device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Concussion; Headache

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Michael Popovich
• Organization: University of Michigan

mipopovi@med.umich.edu

(734) 936-1808

Study Officials

• Michael Popovich, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: March 18, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 6, 2021
• Last Updated: September 14, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Data will be made available if requested, pending a data use agreement.

Locations

US (1)