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Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

Primary Purpose

Post-Traumatic Headache

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Traumatic Headache focused on measuring traumatic brain injury, veteran, VA Connecticut Healthcare System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: United States Military Veterans within VA Connecticut Healthcare System Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury) At least two headache days per week MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years Review of MRI and the medical record does not reveal another source for headache Exclusion Criteria: Skull defect Other contraindication to bupivacaine Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine Instruction from clinician to avoid amide anesthetics, such as lidocaine Pregnant or lack of adequate birth control

Sites / Locations

  • VA Connecticut Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each

bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each

bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each

bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each

Outcomes

Primary Outcome Measures

Acute sensation felt during injection: quality
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Acute sensation felt during injection: intensity
The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale
Paresthesia felt after injection: quality
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Paresthesia felt after injection: intensity
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Paresthesia felt after injection: distribution
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Paresthesia felt after injection: duration
The duration of the sensation over the scalp after injection (hours)

Secondary Outcome Measures

Adverse events
Complications that occur during or after injection

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Yale University
Collaborators
VA Connecticut Healthcare System, National Headache Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06069791
Brief Title
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
Official Title
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
VA Connecticut Healthcare System, National Headache Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.
Detailed Description
Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted. Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden. The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Headache
Keywords
traumatic brain injury, veteran, VA Connecticut Healthcare System

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
incomplete block assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both bupivacaine concentration and order of administration will be unknown except to Research Pharmacy
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each
Arm Title
Group 2
Arm Type
Experimental
Arm Description
bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each
Arm Title
Group 3
Arm Type
Experimental
Arm Description
bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each
Arm Title
Group 4
Arm Type
Experimental
Arm Description
bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
subcutaneous injection around bilateral greater occipital nerves
Primary Outcome Measure Information:
Title
Acute sensation felt during injection: quality
Description
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Time Frame
During injection
Title
Acute sensation felt during injection: intensity
Description
The maximum intensity of the sensation on the scalp at the time of injection on 0-10 numerical rating scale
Time Frame
During injection
Title
Paresthesia felt after injection: quality
Description
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Time Frame
From the time of injection to 1 week after injection
Title
Paresthesia felt after injection: intensity
Description
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Time Frame
From the time of injection to 1 week after injection
Title
Paresthesia felt after injection: distribution
Description
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Time Frame
From the time of injection to 1 week after injection
Title
Paresthesia felt after injection: duration
Description
The duration of the sensation over the scalp after injection (hours)
Time Frame
From the time of injection to 1 week after injection
Secondary Outcome Measure Information:
Title
Adverse events
Description
Complications that occur during or after injection
Time Frame
From the first injection to two weeks after the last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: United States Military Veterans within VA Connecticut Healthcare System Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury) At least two headache days per week MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years Review of MRI and the medical record does not reveal another source for headache Exclusion Criteria: Skull defect Other contraindication to bupivacaine Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine Instruction from clinician to avoid amide anesthetics, such as lidocaine Pregnant or lack of adequate birth control
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle Schindler, MD, PhD
Phone
203-932-5711
Ext
4335
Email
emmanuelle.schindler@va.gov
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Schindler, MD, PhD
Phone
203-932-5711
Ext
4335
Email
emmanuelle.schindler@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

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