Post-Traumatic HeadachePhase 2NCT07796074
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2
A Phase 2 study testing Bupivacaine bilateral greater occipital nerve block in people with Post-Traumatic Headache, run by Yale University at 1 site in United States.
Trial summary
Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e.… 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 bilateral greater occipital nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
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 System1.
- Head injury with headaches that have continued to occur for at least three months after the head injury
- At least two headache days per week
- Review of 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
- Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness/weakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging).
- Absence of imaging warranted by the standard of clinical care for the head injury with headaches.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Emmanuelle Schindler, MD, PhD, 203-932-5711 ext. 14335, emmanuelle.schindler@va.gov
About this study
Official title: Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 2
Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.
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.
In this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.
- Conditions
- Post-Traumatic Headache
- Being tested
- Bupivacaine bilateral greater occipital nerve block
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine bilateral greater occipital nerve blockDrug
Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.0% bupivacaine (normal saline) Receives: Drug: Bupivacaine bilateral greater occipital nerve block |
| Low dose bupivacaine | Active comparator | 0.05% bupivacaine Receives: Drug: Bupivacaine bilateral greater occipital nerve block |
| Full dose bupivacaine | Experimental | 0.5% bupivacaine Receives: Drug: Bupivacaine bilateral greater occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache days/week in the first month
Change in the weekly number of headache days after GON blockade
Measured: From one month before to one month after injection
Secondary outcomes (12)
Change in headache days/week over two months
Change in number of days per week with headache
Measured: From one month before to two months after injection
Change in average headache pain intensity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: From one month before to two months after injection
Change in average attack duration
Hours
Measured: From one month before to two months after injection
Change in average headache-associated light sensitivity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: From one month before to two months after injection
Change in average headache-associated sound sensitivity
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: From one month before to two months after injection
Change in average headache-associated nausea/vomiting
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: From one month before to two months after injection
Change in average headache-associated functional impairment
Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)
Measured: From one month before to two months after injection
Change in average days/week using headache abortive treatment
Number of days per week using an abortive treatment for headache
Measured: From one month before to two months after injection
Patient Global Impression of Change scale (PGIC)
Scale of 1-7 with higher scores indicating worse outcome.
Measured: From one month before to two months after injection
Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ)
0-to-100 scale. Higher scores indicate better quality of life.
Measured: From one month before to two months after injection
Migraine Disability Assessment (MIDAS)
Score from 0 to 270. Higher scores indicating more severe disability.
Measured: From one month before to two months after injection
Number of participants with Adverse events
Number of participants with Adverse events that occur during or after injection
Measured: From one month before to two months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System, National Headache Foundation
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Schindler, MD, PhD, Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796074
- Sponsor's protocol ID
- 1656679_a
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in this study include patient information that must remain behind the US Veterans Affairs firewall.