Post-Traumatic HeadachePhase 1NCT06069791
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
A Phase 1 study testing Bupivacaine Injection in people with Post-Traumatic Headache, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
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.
Read the 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).
- Conditions
- Post-Traumatic Headache
- Being tested
- Bupivacaine Injection
- Keywords
- traumatic brain injury, veteran, VA Connecticut Healthcare System
- Medical subject headings
- Post-Traumatic Headache, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine InjectionDrug
subcutaneous injection around bilateral greater occipital nerves
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | bupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each Receives: Drug: Bupivacaine Injection |
| Group 2 | Experimental | bupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each Receives: Drug: Bupivacaine Injection |
| Group 3 | Experimental | bupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each Receives: Drug: Bupivacaine Injection |
| Group 4 | Experimental | bupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each Receives: Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute sensation felt during injection: quality
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Measured: During injection
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
Measured: During injection
Paresthesia felt after injection: quality
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Measured: From the time of injection to 1 week after injection
Paresthesia felt after injection: intensity
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Measured: From the time of injection to 1 week after injection
Paresthesia felt after injection: distribution
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Measured: From the time of injection to 1 week after injection
Paresthesia felt after injection: duration
The duration of the sensation over the scalp after injection (hours)
Measured: From the time of injection to 1 week after injection
Secondary outcomes (1)
Adverse events
Complications that occur during or after injection
Measured: From the first injection to two weeks after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start26 Jan 2024
- Primary completion23 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- incomplete block assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System, National Headache Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069791
- Sponsor's protocol ID
- 1656679
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
- ClinicalTrials.gov ID
- NCT06069791
- Acronym / sponsor ID
- 1656679
- Conditions
- Post-Traumatic Headache
- Keywords
- traumatic brain injury, veteran, VA Connecticut Healthcare System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System, National Headache Foundation
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- incomplete block assignment
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Bupivacaine Injectionbupivacaine 0.0%, 0.01%, and 0.05% in random order, one week apart each |
| Group 2 | Experimental | Drug: Bupivacaine Injectionbupivacaine 0.1%, 0.05%, and 0.1% in random order, one week apart each |
| Group 3 | Experimental | Drug: Bupivacaine Injectionbupivacaine 0.0%, 0.1%, and 0.5% in random order, one week apart each |
| Group 4 | Experimental | Drug: Bupivacaine Injectionbupivacaine [0.01% or 0.05%], [0.05% or 0.1%], and 0.05% in random order, one week apart each |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Skull defect
- Other contraindication to bupivacaine
- Pregnant or lack of adequate birth control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Injectionsubcutaneous injection around bilateral greater occipital nerves | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Acute sensation felt during injection: quality
Time frame: During injection
The quality of the sensation on the scalp at the time of injection (e.g., burning, shooting, aching)
Acute sensation felt during injection: intensity
Time frame: During injection
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
Time frame: From the time of injection to 1 week after injection
The quality of the sensation over the scalp after injection (e.g., numbing, tingling, coolness)
Paresthesia felt after injection: intensity
Time frame: From the time of injection to 1 week after injection
The maximum intensity of the sensation over the scalp after injection on 0-10 numerical rating scale
Paresthesia felt after injection: distribution
Time frame: From the time of injection to 1 week after injection
The location of the sensation over the scalp after injection, drawn on figure of head and neck
Paresthesia felt after injection: duration
Time frame: From the time of injection to 1 week after injection
The duration of the sensation over the scalp after injection (hours)
1 secondary outcome
Adverse events
Time frame: From the first injection to two weeks after the last injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Traumatic Headache
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine Injection in people with Post-Traumatic Headache, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute sensation felt during injection: quality (time frame: During injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.