Back to results

Sphenopalatine Ganglion Block for Headache After Concussion

Primary Purpose

Concussion, Headache

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lidocaine in SphenoCath device

Saline Solution in SphenoCath device

About this trial

This is an interventional treatment trial for Concussion focused on measuring Concussions, headaches, sphenopalatine ganglion block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine in SphenoCath device

Saline Solution in SphenoCath device

Arm Description

One treatment will be given.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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.

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.

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.

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.

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.

Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block

Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block

Mean Change in the Number of Days With Headache

Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.

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.

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.

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.

Full Information

NCT ID

NCT04650282

First Posted

November 24, 2020

Last Updated

August 29, 2022

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT04650282

Brief Title

Sphenopalatine Ganglion Block for Headache After Concussion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Reassignment of PI to more intense clinical obligations prevents continuation of the trial.

Study Start Date

March 18, 2021 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

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.

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion, Headache

Keywords

Concussions, headaches, sphenopalatine ganglion block

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine in SphenoCath device

Arm Type

Experimental

Arm Description

One treatment will be given.

Arm Title

Saline Solution in SphenoCath device

Arm Type

Placebo Comparator

Arm Description

One treatment will be given.

Intervention Type

Combination Product

Intervention Name(s)

Lidocaine in SphenoCath device

Intervention Description

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

Intervention Name(s)

Saline Solution in SphenoCath device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Change in Headache Severity Score

Description

Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."

Time Frame

48 hours pre-SPG to 48 hours after SPG block

Secondary Outcome Measure Information:

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

2, 24 hours after SPG block

Title

Mean Change in the Number of Headache Occurrences

Description

The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.

Time Frame

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

Title

Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block

Description

The number of headache episodes prior to the SPG block to after the procedure.

Time Frame

48 hours pre SPG to 48 hours post block

Title

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

Description

The number of headache episodes over the one week prior to the SPG block to one week after the procedure.

Time Frame

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

Title

Mean Change in Headache Hours Per Day

Description

The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.

Time Frame

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

Title

Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block

Time Frame

48 hours pre SPG up to 48 hours post SPG

Title

Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block

Time Frame

1 week before SPG block to 1 week post SPG block

Title

Mean Change in the Number of Days With Headache

Time Frame

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

Title

Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.

Time Frame

1 week before SPG block up to 1 week post SPG

Title

Mean Change in As-needed Headache Treatment Uses

Description

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.

Time Frame

1 week before SPG block to 1 week post SPG block

Title

Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG

Description

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.

Time Frame

48 hours before SPG block to 48 hours post SPG block

Title

Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Popovich, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Sphenopalatine Ganglion Block for Headache After Concussion

We'll reach out to this number within 24 hrs