Actively Recruiting
Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 1
Led by Yale University · Updated on 2026-01-29
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
V
VA Connecticut Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the acute and subacute sensations experienced on the scalp when different concentrations of bupivacaine are injected for greater occipital nerve blockade in Veterans with post-traumatic headache (PTH). Military Servicemembers and Veterans are at higher risk of traumatic brain injury, which can lead to PTH, often resembling migraine. Current treatments have limitations, so this study explores a nerve blockade method that might offer relief. Participants will receive three different concentrations of bupivacaine injections around the bilateral greater occipital nerves, administered one week apart in a randomized order. The concentrations tested include 0.0%, 0.01%, 0.05%, 0.1%, and 0.5% in various combinations to identify which lower dose best mimics the sensations of the full dose (0.5%) for use in a future trial. During the study, participants will report on the quality, intensity, distribution, and duration of sensations during and after each injection, up to one week following. Researchers will monitor for any adverse events from the first injection until two weeks after the last injection. The study involves multiple injections spaced one week apart, with detailed sensory assessments to measure the nerve blockade effects.
CONDITIONS
Brief Title
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- United States Military Veterans within VA Connecticut Healthcare System
- Chronic post-traumatic headache per ICHD-3 criteria (headaches continuing at least 3 months after head injury)
- At least two headache days per week
- MRI brain scan completed within past 3 months if chronic PTH less than 1 year
- MRI brain scan within past year if chronic PTH less than 5 years
- MRI brain scan within past 5 years if chronic PTH more than 10 years
- Review of MRI and medical record shows no other cause for headache
You will not qualify if you...
- Skull defect
- Allergy or adverse reaction to amide anesthetics like lidocaine
- Instruction from clinician to avoid amide anesthetics
- Pregnant or lack of adequate birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive subcutaneous injections of different concentrations of bupivacaine around bilateral greater occipital nerves in a randomized crossover design, with each injection spaced one week apart.
3 visits (in-person), one visit per injection spaced one week apart
Duration - Up to 2 weeks after last injection
Participants are monitored for sensations and any adverse events from the time of injection up to two weeks after the last injection.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
E
Emmanuelle Schindler, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
4
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